Sulfacetamide sodium ophthalmic solution

Bleph

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/7/2020

What Is Bleph?

Bleph-10 (sulfacetamide sodium ophthalmic solution 10%) is an antibiotic used to treat bacterial infections of the eyes. Bleph-10 is available in generic form.

What Are Side Effects of Bleph?

Common side effects of Bleph-10 include:

  • eye stinging/burning/redness/itching/irritation,
  • temporary blurred vision,
  • eyelid itching,
  • eyelid swelling, or
  • sensitivity to light.

Stop using Bleph-10 and contact your doctor if you notice new or worsening eye symptoms (such as pain, swelling, thick discharge, or pus).

Dosage for Bleph

The dose of Bleph-10 to treat conjunctivitis and other superficial eye infections: instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially.

What Drugs, Substances, or Supplements Interact with Bleph?

Bleph-10 may interact with other eye drops containing nitrates (e.g., silver nitrate). Do not use other eye drops or medications during treatment with Bleph-10 ophthalmic unless directed by your doctor. Other drugs may interact with Bleph-10 ophthalmic

.

Bleph During Pregnancy and Breastfeeding

Tell your doctor all prescription or over-the-counter medicines and supplements you use. During pregnancy, Bleph-10 should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Bleph-10 (sulfacetamide sodium ophthalmic solution 10%) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sulfacetamide Sodium Ophthalmic Dosage

Medically reviewed by Drugs.com. Last updated on May 9, 2019.

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Applies to the following strengths: 10%; 15%; 30%

Usual Adult Dose for:

  • Ocular Infection
  • Conjunctivitis
  • Trachoma

Usual Pediatric Dose for:

  • Ocular Infection
  • Conjunctivitis
  • Trachoma

Additional dosage information:

  • Renal Dose Adjustments
  • Liver Dose Adjustments
  • Precautions
  • Dialysis
  • Other Comments

Usual Adult Dose for Ocular Infection

Ointment: Apply a small amount (about 1/2 inch ribbon) into the conjunctival sac(s) of the infected eye(s) every 3 to 4 hours and at bedtime.
Solution: Instill 1 to 2 drops into the conjunctival sac(s) of the affected eye(s) every 2 to 3 hours initially.
Duration of therapy: 7 to 10 days

-As the condition responds, may taper by increasing the time interval between doses
-May use the ointment as adjunct to the solution
Uses: For the treatment of conjunctivitis and other superficial ocular infections due to susceptible Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, Enterobacter species

Usual Adult Dose for Trachoma

Solution: Instill 2 drops into the conjunctival sac(s) of the affected eye(s) every 2 hours.
Comments: For use with systemic therapy
Use: As an adjunct to systemic sulfonamide therapy of trachoma

Usual Pediatric Dose for Ocular Infection

2 months or older:
-Ointment: Apply a small amount (about 1/2 inch ribbon) into the conjunctival sac(s) of the infected eye(s) every 3 to 4 hours and at bedtime.
-Solution: Instill 1 to 2 drops into the conjunctival sac(s) of the infected eye(s) every 2 to 3 hours initially.
Duration of therapy: 7 to 10 days

-As the condition responds, may taper by increasing the time interval between doses
-May use the ointment as adjunct to the solution
Uses: For the treatment of conjunctivitis and other superficial ocular infections due to susceptible E coli, S aureus, S pneumoniae, Streptococcus (viridans group), H influenzae, Klebsiella species, Enterobacter species

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 2 months.
Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Storage requirements:
-Ointment: Store at 20C to 25C (68F to 77F).
-Solution: Store at 8C to 25C (46F to 77F); protect from light.
General:
-Topically applied sulfonamides provide insufficient coverage against Neisseria species, Serratia marcescens, and Pseudomonas aeruginosa.
-A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
-Sulfonamide solution color will darken over time and should be discarded.
Patient advice:
-Avoid contaminating the applicator tip through contact with the eye, eyelid, or any other surface.
-Discontinue therapy and contact physician at first sign of hypersensitivity, if purulent discharge increases, or if inflammation/pain worsens.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about sulfacetamide sodium ophthalmic

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  • Drug class: ophthalmic anti-infectives
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Consumer resources

  • Sulfacetamide ophthalmic
  • Sulfacetamide Eye Drops
  • Sulfacetamide Eye Ointment

Other brands: Bleph-10

Professional resources

  • Sulfacetamide (AHFS Monograph)
  • … +4 more

Related treatment guides

  • Conjunctivitis
  • Eye Conditions
  • Trachoma

Sulfacetamide Sodium Ophthalmic

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not use this medicine while wearing contact lenses. Sulfacetamide ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

Wash your hands before using eye medication.

To use this medicine:

  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket.
  • Eye drops: Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop. Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.
  • Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.
  • Wait at least 10 minutes before using any other eye drops your doctor has prescribed.
  • Eye ointment: Hold the ointment tube with the tip pointing toward this pocket. Look up and away from the tip. Squeeze out a ribbon of ointment into the lower eyelid pocket without touching the tip of the tube to your eye. Blink your eye gently and then keep it closed for 1 or 2 minutes.
  • Use a tissue to wipe excess ointment from your eyelashes.
  • After opening your eyes, you may have blurred vision for a short time. Avoid driving or doing anything that requires you to be able to see clearly.

Do not touch the tip of the eye dropper or ointment tube. Do not place the tip directly on your eye. A contaminated dropper or tube can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle or tube tightly closed when not in use.

An overdose of sulfacetamide ophthalmic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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Latest Update: 11/9/2018, Version: 6.02

Dodd-Frank Wall Street Reform

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

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FOR FURTHER INFORMATION CONTACT:

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SUPPLEMENTARY INFORMATION:

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.

FDA has become aware that the drug products listed in the table in this document are no longer being marketed. (As requested by the applicant, FDA withdrew approval of NDA 005963 for SODIUM SULAMYD (sulfacetamide sodium) Ophthalmic Solution and Ophthalmic Ointment in the Federal Register of August 16, 2001 (66 FR 43017)).

Application No. Drug Applicant
NDA 005963 SODIUM SULAMYD (sulfacetamide sodium) Ophthalmic Solution 10%, Ophthalmic Solution 30%, and Ophthalmic Ointment 10% Schering Plough Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.

FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.Start Printed Page 27321

Approved ANDAs that refer to the NDA listed in this document are unaffected by the discontinued marketing of the products subject to this NDA. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

Start Signature

Dated: May 7, 2015.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

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Eye drops recall at Walmart, CVS, Walgreens

Eye Care

By Jeff Herman, chief editor

If you’re using eye drops or eye ointments, you should check your medicine cabinet, nightstand or desk drawer in the wake of voluntary recalls by Altaire Pharmaceuticals.

The maker of eye drops for dry eye, rewetting drops and eye ointments sold at CVS, Walgreens and Walmart cited concerns about sterility of the ophthalmic products made at its manufacturing facility, according to the Food and Drug Administration.

Why is sterility important?

As the FDA notes, “administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.”

The FDA news releases issued early in July 2019 detail Altaire’s voluntary recalls of eye care products made for CVS Health , Perrigo , Walgreens and Walmart .

The voluntary recall has since expanded to include over-the-counter and prescription eye care products sold under the Altaire brand name and products labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc., Natural Ophthalmics , OCuSOFT , Prestige and TRP Co.

Altair reports that to date it has not received any reports of adverse effects from the voluntarily recalled products, nor has Altaire found any out-of-specifications outcomes of sterility testing for the products.

The voluntarily recalled products are:

Accutome

Accutome Accu-Wash, Product Size: 4 oz.

Altaire brand eye drops and products recalled

ActivEyes Nighttime Lub Eye Ointment Preservative Free, Product Size: 3.5 g

Altaire Altacaine Solution, Product Size: 15 mL

ActivEyes Altachlore Ointment, Product Size: 3.5 gram

ActivEyes Altachlore Solution, Product Size: 15 mL

ActivEyes Altalube Ointment, Product Size: 3.5 gram

Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, Product Size: 2.5 mL

Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, Product Size: 5 mL

Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, Product Size: 10 mL

Altaire Diclofenac Sodium Solution 1%, Product Size: 2.5 mL

Altaire Diclofenac Sodium Solution 1%, Product Size: 5 mL

Altaire Fluorescein Sodium with Proparacaine HCl Ophthalmic Solution, Product Size: 5 mL

Altaire Eye Wash, Product Size: 15 mL

Altaire Eye Wash, Product Size: 1 oz.

Altaire Eye Wash, Product Size: 4 oz.

Altaire Goniotaire, Product Size: 15 mL

Altaire Homatropaire, Product Size: 5 mL

NanoTears HA PF Multi Dose Lubricant Gel Drops, Product Size: 10 mL

Nano Tears MO Clear Emollient Mineral Oil Lipids, Product Size: 10 mL

Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Product Size: 10 mL

Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack: 2 x 10 mL

Nano Tears TF Clear Emollient Tear Film Replenishment Essential Lipids Preservative Free Multi-Dose, Product Size: 7.5 mL

Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct.

Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct.

Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL

Nano Tears TF Clear Emollient Lubricant Gel Drops, Product Size: 15 mL

Nano Tears XP Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL

Nano Tears XP Clear Emollient Lubricant Gel Drops, Product Size: 10 mL

Altaire Ofloxacin 0.3% Ophthalmic Solution, Product Size: 5 mL

ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF, Product Size: 7.5 mL

ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF, Product Size: 7.5 mL

ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram

CVS brand eye drops and products recalled

CVS Health Natural Tears Lubricant Eye Drops Preservative Free, Product Size: 0.6 mL x 32 ct

CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Product Size: 15 mL

CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Product Size: 30 mL

CVS Health Dry Eye Relief Eye Drops, Product Size: 15 mL

CVS Health Dry Eye Relief Eye Drops, Product Size: 30 mL

CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Product Size: 0.6 mL x 60 ct

CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Product Size: 0. 6 mL x 30 ct

CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Product Size: 0.6 mL x 30

CVS Health Lubricating Gel Drops for Anytime Use, Product Size: 10 mL

CVS Health Overnight Lubricating Eye Ointment, Product Size: 3.5 gram

CVS Health Lubricant Eye Ointment, Product Size: 3.5 gram

CVS Health Extra Strength Lubricant Gel Drops, Product Size: 15 mL

CVS Health Extra Strength Lubricant Gel Drops Twin Pack, 2 x 15 mL

CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Product Size: 15 mL

CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy Twin Pack, Product Size: 2 x 10 mL

CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Product Size: 0.6 mL x 30ct

CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Product Size: 0.6 mL x 70ct

CVS Health Preservative Free Lubricant Eye Drops Advanced Relief, Product Size: 0.6 mL x 30

CVS Health Lubricant Eye Drops Advanced Relief, Product Size: 10 mL

CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Product Size: 0.6 mL x 24 ct

CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Product Size: 0.6 mL x 60 ct

CVS Health Lubricant Gel Drops-Moderate to Severe Dry Eye Relief, Product Size: 30 mL

CVS Health Lubricant Gel Drops-Moderate to Severe Dry Eye Relief, Product Size: 30 mL

CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Product Size: 10 mL

CVS Health Lubricant Eye Drops Lasting Dry Eye Relief Twin Pack, Product Size: 2 x 10 mL

CVS Health Maximum Redness Relief Eye Drops, Product Size: 15 mL

CVS Health Redness Relief, Product Size: 15 mL

CVS Health Redness Relief, Product Size: 30 mL

CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Product Size: 15 mL

CVS Health Lubricant Eye Ointment Sensitive Formula, Product Size: 3.5 gram

Perrigo eye drops and products recalled

Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment, Package Size: 3.5 gm

NEO-POLY DEX (Neomycin and Polymixin B and Dexamethasone) Ophthalmic Ointment, Package Size: 3.5 gm

NEO-POLYCIN HC (Neomycin and Polymixin B and Bacitracin Zinc and Hydrocortisone Acetate) Ophthalmic Ointment, Package Size: 3.5 gm

POLYCIN (Polymixin B and Bacitracin Zinc) Ophthalmic Ointment, Package Size: 3.5 gm

Bacitracin Ophthalmic Ointment, Package Size: 3.5 gm

Sulfacetamide Sodium Ophthalmic Ointment, Package Size: 3.5 gm

Puralube Ophthalmic Ointment (Please note: Puralube is an OTC product), Package Size: 3.5 gm

Puralube Ophthalmic Ointment (Please note: Puralube is an OTC product), Package Size: 1 gm

Focus Laboratories

FreshKote Lubricant Eye Drops , Product Size: 15 mL

Grandall Distributing Co. Inc.

Grandall Colirio Ojo De Aguila Eye Drops , Product Size: 15 mL

Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL

Grandall Oftal-Mycin Ophthalmic Ointment , Product Size: 3.5 gm

Natural Ophthalmics

Natural Ophthalmics Ortho-K Thick Comfort Gel , Product Size: 15 mL

Natural Ophthalmics Women’s Tear Stimulation Dry Eye Drops, Product Size: 15 mL

Natural Ophthalmics Ortho-K Thin Eye Drops, Product Size: 15 mL

Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops, Product Size: 15 mL

Natural Ophthalmics Cataract Eye Drops with Cineraria, Product Size: 15 mL

Natural Ophthalmics Allergy Desensitization Eye Drops , Product Size: 15 mL

OCuSOFT

OCuSOFT Homatropine Hydrobromide Ophthalmic Solution 5%, Product Size: 5 mL

OCuSOFT Tetcaine Hydrochloride Ophthalmic Solution USP, 0. 5%, Product Size: 15 mL

OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Product Size: 15 mL

OCuSOFT Tetravisc Forte, Product Size: 0.6 mL x 12 pcs

OCuSOFT Tetravisc Forte, Product Size: 5 mL

OCuSOFT Tetravisc, Product Size: 0.6 mL x 12 pcs

OCuSOFT Tetravisc , Product Size: 5 mL

OCuSOFT Flucaine, Product Size: 5 mL

OCuSOFT Eye Wash, Product Size: 1 oz

OCuSOFT Eye Wash, Product Size: 4 oz

OCuSOFT Tears Again Lubricant Eye Drops , Product Size: 15 mL

OCuSOFT Tears Again Lubricant Eye Drops, Product Size: 30 mL

OCuSOFT Tears Again Lubricant Eye Ointment Nighttime Relief, Product Size: 3.5 g

OCuSOFT retaine NaCl Ophthalmic Ointment , Product Size: 3.5 g

OCuSOFT retaine NaCl Ophthalmic Solution, Product Size: 15 mL

Prestige

Clear Eyes Redness Relief , Product Size: 15 mL

Clear Eyes Redness Relief , Product Size: 30 mL

Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 oz.

Clear Eyes Redness Relief (Little Drug) , Product Size: 0.2 oz.

Clear Eyes Redness Relief (Select Corp) , Product Size: 0.2 oz.

TRP

TRP/TARGET up & up intensive relief lubricating eye drops, Product Size: 10 mL

TRP Blur Relief , Product Size: 15 mL

TRP Stye Relief , Product Size: 4 g

TRP Pink Eye Relief , Product Size: 10 mL

Walgreens brand eye drops and ointments recalled

Lubricant Eye Drops Moisturizing, Package Size: 15 mL

Lubricant Eye Drops Moisturizing Twin Pack, Package Size: 2 x 15 mL

Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment, Package Size: 3.5 gram

Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, Package Size: 15 mL

Lubricant Eye Ointment PF Soothing, Package Size: 3.5 gram

Walmart brand eye drops and ointments recalled

Equate Restore Tears Lubricant Eye Drops Twin Pack, Package Size: 2 x 15 mL

Equate Eye Allergy Relief Drops, Package Size: 15 mL

Equate Sterile Lubricant Stye Ointment, Package Size: 3.5 gram

Equate Comfort Gel Lubricant Eye Gel Twin Pack, Package Size: 2 x 15 mL

Equate Restore PM Nighttime Lubricant Eye Ointment, Package Size: 3.5 gram

Equate Night & Day Restore Tears Lubricant Eye Pack, Package Size: 3.5g and 15mL

Equate Support Advanced Twin Pack, Package Size: 2 x 15 mL

Equate Support Advanced Lubricating Eye Drops Dose Preservative Free, Package Size: 25 count (0.6 mL fill)

Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, Package Size: 7.5 mL

Equate Support Moisture Lubricant Eye Drops, Package Size:10 mL

Support Harmony Lubricant Eye Drops, Package Size: 10 mL (Note: Support Harmony packaging was discontinued in January 2018.)

July 2019

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