Ammonium lactate 12 lotion

Ammonium lactate topical

Generic Name: ammonium lactate topical (a MOE nee um LAK tate)
Brand Name: Amlactin, Geri-Hydrolac, Kerasal AL, Lac-Hydrin, Laclotion, Lac-Hydrin 5, AmLactin Foot Cream Therapy, Amlactin XL, Amlactin Ultra, AmLactin Cerapeutic

Medically reviewed by on Oct 28, 2019 – Written by Cerner Multum

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What is ammonium lactate?

Ammonium lactate is a combination of lactic acid and ammonium hydroxide. Ammonium lactate is a moisturizer.

Ammonium lactate is used to treat dry, scaly, itchy skin.

Ammonium lactate may also be used for purposes not listed in this medication guide.

Important Information

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use this medication if you are allergic to ammonium lactate, glycerin, mineral oil, propylene glycol, or parabens.

Ammonium lactate may be more likely to cause skin irritation in people who have fair or sensitive skin.

FDA pregnancy category C. It is not known whether ammonium lactate topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether ammonium lactate topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give ammonium lactate topical to a child without medical advice.

How should I apply ammonium lactate?

Ammonium lactate is usually applied twice a day. Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Shake the lotion form of this medication well just before using it.

Wash your hands before and after applying this medication, unless you are using it to treat a hand condition.

Do not apply ammonium lactate to your face unless your doctor has told you to.

Call your doctor if your symptoms do not improve, or if they get worse while using ammonium lactate topical.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose is unlikely to occur with the use of ammonium lactate topical.

What should I avoid while using ammonium lactate?

Do not take by mouth. Ammonium lactate topical is for use only on the skin. Do not use ammonium lactate topical on open wounds or on sunburned, windburned, dry, chapped, or irritated skin. If this medication gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Ammonium lactate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ammonium lactate topical and call your doctor at once if you have:

  • severe redness or stinging where the medicine was applied.

Common side effects may include:

  • mild dryness or skin irritation after use; or

  • bruising of discoloration of treated skin.

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.

Ammonium lactate topical dosing information

Usual Adult Dose for Pruritus:

Shake well. Apply topically to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

Usual Adult Dose for Ichthyosis:

Shake well. Apply topically to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

Usual Adult Dose for Xerosis:

Shake well. Apply topically to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

What other drugs will affect ammonium lactate?

It is not likely that other drugs you take orally or inject will have an effect on topically applied ammonium lactate. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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

Copyright 1996-2018 Cerner Multum, Inc. Version: 5.03.

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  • Drug class: topical emollients

Consumer resources

  • Lactic Acid and Ammonium Hydroxide Cream
  • Lactic Acid and Ammonium Hydroxide Lotion

Other brands: AmLactin, Lac-Hydrin, Geri-Hydrolac, Kerasal AL, Laclotion

Professional resources

  • Ammonium Lactate (FDA)
  • … +1 more

Related treatment guides

  • Ichthyosis
  • Pruritus
  • Dry Skin

Ammonium Lactate skin cream

What is this medicine?

AMMONIUM LACTATE (uh MOH nee uh m LAK teyt) is used on the skin to treat dry skin and other skin conditions.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Amlactin, Amlactin Ultra, LAC-cream, Lac-Hydrin

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • frequent exposure to sunlight

  • an unusual or allergic reaction to ammonium lactate, propylene glycol, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

This medicine is for external use only. Follow the directions on the prescription label. Wash your hands before and after use. Make sure the skin is clean and dry. Apply just enough cream to cover the affected area. Rub in gently but completely. Avoid contact with broken skin such as skin cuts or abrasions. If accidental contact occurs, large amounts of water should be used to wash the affected area. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. Do not use your medicine more often than directed. Do not to use more medicine than prescribed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Interactions are not expected. Do not use any other skin products without asking your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your skin condition gets worse or does not get better within 4 weeks.

Avoid using this medicine on areas of skin that may be exposed to natural or artificial sunlight, including the face. If you can not avoid sun exposure, wear clothing to protect the skin.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • severe dry skin, peeling

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • dry or irritated skin

  • increased sensitivity to the sun

  • mild reddening or peeling of the skin

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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Year : 2002 | Volume : 68 | Issue : 3 | Page : 137-139

Long term topical application of lactic acid/lactate lotion as a preventive treatment for acne vulgaris
Taru Garg , M Ramam , JS Pasricha , KK Verma
Department of Dermatology and Venereology, All India Institute of Medical Science, New Delhi, India

Correspondence Address:
Department of Dermatology and Venereology, All India Institute of Medical Science, New Delhi, India


In an open clinical study, efficacy of 5% aqueous solution of lactate for preventing acne was evaluated IN 22 patients. Lactate lotion was used topically all over the face twice a day and continued like a cosmetic for 1 year. Systematic antibiotics were given for periods of 4 weeks whenever the disease was severe. The effect of the treatment was evaluated by counting the number of comedones, inflammatory lesions and cysts separately once a month and recording them graphically. The greatest reduction in the lesion counts was achieved in 8-24 weeks for the inflammatory lesions and 8-30 weeks for the comedones. At the end of 1 year 90-100% reduction of the inflammatory lesions was achieved in 40.9% patients and non-inflammatory lesions in 22.7% patients. The remaining patients showed 50-90% reduction, while 2 patients showed less than 50% reduction in the non-inflammatory lesions. Thus, most of the patients showed significant reduction in the lesion counts. Aggravations were associated with the hot and the rainy season and required concomitant treatment with oral antibiotics.

How to cite this article:
Garg T, Ramam M, Pasricha J S, Verma K K. Long term topical application of lactic acid/lactate lotion as a preventive treatment for acne vulgaris. Indian J Dermatol Venereol Leprol 2002;68:137-9


Acne is a disorder involving the pilosebaceous units in the skin of the face, and the upper trunk. The agents available for the treatment of acne include topical agents such as 2% and 4% erythromycin with or without. 1.2% zinc acetate, 1 % clindamycin, 2.5-10% benzoyl peroxide, 0.025-0.1 % tretinion, 0.025% adapalene, and 20% azelaic acid. Each of these agents is highly effective for the treatment of acne, but almost invariably there is a recurrence of the lesions whenever the treatment is stopped, unless the tendency for developing acne has subsided by that time. In most patients, the disease tends to keep recurrring till the age of 25 years and thus the treatment has to be continued for all this period. Under these circumstances, the ideal approach would be to depend upon a topical treatment which can be used like a cosmetic on a regular basis and prevent acne till the patient is no more prone to develop acne. Such an agent has to be cosmetically acceptable and safe on prolonged usage.
With these considerations, Pasricha had used a formulation based on lactic acid/lactate system for the management of acne. Lactic acid/ lactate is a cimponent of the normal skin-surface chemistry, and laboratory studies had revealed that lactic acid and sodium lactate both have a wide spectrum of antibacterial activity and thus this possibly contributes significantly to the natural defence mechanisms of the skin. Being produced by the skin itself, lactic acid is not expected to cause any allergic or toxic reactions. The present study was undertaken to evaluate if a regular use of topical applications of lactate lotion like a cosmetic can control acne.

Materials and methods

Forty consecutive patients having acne vulgaris were enrolled for the study, but only 22 patients completed the study period of 1 year. Pregnant woman, patients on oral contraceptives and patients known to have liver or adrenal dysfunction or any other systemic disease were excluded. The lesions present on the face at the rime of starting the treatment were counted and classified into, non-inflammatory lesions (open and closed comedones), inflammatory lesions (papules and pustules), and cystic lesions.
The patients were instructed to apply the 5% lactate lotion prepared in an aqueous base all over the face twice a day, after washing the face thoroughly with soap and water. Applications of the lactate lotion were continued even when the patient had no lesions. Patients having severe disease were in addition given 100 mg doxycycline per day for a period of 4 weeks. If the response to doxycycline was not adequate, the antibiotic was changed to ciprofloxacin 500 mg twice a day or erythromycin 500 mg twice a day for 4 weeks. Treatment with the antibiotic was repeated whenever the patient had severe exacerbations.
Re-evaluation was undertaken once a month when the lesions were counted separately for each category at each visit. The severity of the disease during follow up was recorded graphically.


Twenty-two patients, 17 males and 5 females, with duration of disease ranging from 15 years cimpleted the study. The lesion counts at the start of the treatment were 6-52 (21.27) for the inflammatory lesions, 5-293 (97.36) for the non-inflammatory lesions and 0-19 (3.18) for the cysts. At the end of the 1 year of treatment the lesions counts were 1-12 (4.64) for the inflammatory lesions, and 2-89 (19.18 for the non-inflammatory lesions. Cysts had disappeared in all the patients.
The maximal reduction with respect to the comedones was achieved between 8-30 weeks, and at the end of the first year, 5 (22.7%) patients had 90-100% improvement and 13 (59%) improvement. Two patients had less than 50% improvement.
The maximal reduction in the inflammatory lesion counts was achieved between 8-24 weeks and at the end of the first year, 9 (40.9%) patients had 50-90% reduction in the lesion counts. Cysts had disappeared in 2 patients at the end of 8 weeks, in 3 patients at 12 weeks, in 1 patient each at 16 and 20 weeks. In 5 patients cystic lesions developed during the treatment bur disappeared in 4 weeks in 4 patients and 8 weeks in 1 patient.
One patient did not show any change in the inflammatory lesions and the comedones and in another patient the lesion counts were higher at the end of 1 year with respect to both the comedones and the inflammatory lesions.
Doxycycline was given to 14 patients for 4-12 weeks at the beginning of the treatment because they severe acne. Seven of these patients showed an adequate response. The other 7 patients who did not respond adequately to doxycycline were given ciprofloxacin. Five of these patients responded to ciprofloxacin, and received the drug for 4-16 weeks. The patients who did not respond to even ciprofloxacin were given erythromycin, but only one of these responded to erythromycin. During the subsequent follow up, only 8 of these patients required systemic antibiotics to control the aggravations during the course of the disease.

Of the remaining 8 patients who did not need systemic antibiotic in the beginning, 6 required the antibiotics to control the aggravations during the course of the disease. All these patients were first given doxycycline, but 4 patients who did not show adequate response to doxycycline, were given ciprofloxacin and one of these patients who still did not respond adequately, was give erythromycin. The duration of the antibiotic therapy to control aggravations in these patients ranged from 4 to 20 weeks. Two patients did not require systemic antibiotics at all throughout the study period.
The aggrvating factors considered responsible for the aggravations by the patients before the start of the therapy were, diet in 2 patients, premenstrual flare in 2 patients, summer season in 9 patients, winter season in 1 patient and topical application of cream containing betamethasone and neomycin in 1 patient. During the treatment, the aggravating factors were psychological stress in 9 patients, premenstrual flare in 2 patients, application of hair oil in 2 patients and summer and rainly season in 16 patients. None of the patients considered food as the aggravating factor.
The side-effects observed during the treatment with ropical lactate were minimal and insignificant. These consisted of temporary pricking sensation over the lesions (27%), irritation (4.5%) and oilness of the face (18%). All these symptoms disappeared after the first few days. Nausea and abdominal disconfort were observed in 27% cases during the treatment with systemic antibiotics. None of the patients discontinued the treatment because of the side-effects.


The conventional aproach for the treatment of one consists of using topical and/or systemic drugs along with other measures, and most of the remedies are useful for controlling the disease and mading the lesions disappeat. The main problem in acne however is that the lesions start appearing again whenever the treatment is withdrawn and this leads to a lot of frustration among the patients and also among the dermatologists. We feel that the rational approach for the management of acne should be to prevent acne so that the patient does not develop the lesions and the resultant scars. For this, it is essential to develop a schedule which can be used on a regular basis right from the time that the patient becomes vulnerable to develop acne (i.e. puberty) and continued up to the age of at least 25 years when the patient spontaneously stops developing further acne lesions.
Of the different medicines available for the topical treatment of acne, locate lotion is the only remedy which is non-toxic and non sensitizing as its main constituent is a normal metabiolite of the body. It was introduced for the treatment of acne with the presumption that the individuals who develop more severe forms of acne are probably secreting less lactic acid on their skin surface. Topical applications of lactic acid would thus reinforce the natural mechanism for controlling the bacterial proliferation on the skin. The range of antibacterial activity of lactic acid/lactate had been shown to cover most of the pathogenic bacteria of significance to dermatology. Swanbeck had also proposed a similar mechanism for ethyl lactate, i.e. that ethyl lactate applied topically would penetrate the sebaceous follicle ducts where it would be hydrolysed to ethanol and lactic acid and thus reduce the pH. As a consequence, the bacterial lipolysis of sebum triglycerides to free fatty acids would be reduced., It seens however, that he failed to realize that lactic acid and even lactate have strong and a wide range of antibacterial activity.
A previous study on the efficacy of topical 5% lactate lotion in the treatment of acne vulgaris showed 61 % improvement in the inflammatory lesions and 43.3% in the non-inflammatory lesions at the end of 12 weeks.
Management of acne is an art. The essential cimponents of the treatment include, a thorough cleaning of the skin and the hair, avoidance of greasy applications (hair oils and creams) to the skin and hair, regular use like a cosmetic of a topical antibacterial agent to prevent acne, and imtermittent use of systemic antibiotics whenever the disease is more severe.
Thus, with appropriate management and judicious use of additional modalities, the effect of acne can be reduced and the need for systemic antibiotics can be further minimized.

1. Pasricha JS. Treatment of skin diseases, 4th edition, Oxford and IBH, New Delhi 1991;p223-36.
2. Pasricha A, Bhalla P, Sharma KB. Evaluation of lactic acid as an antibacterial agent. Indian J Dermatol Venereal Leprol 1979;45:159-161.
3. Pasricha JS. Treatment of skin diseases, 2nd edition, Oxford and IBH, New Delhi 1979;p 143.
4. Swanbeck G. A New principle for the treatment of Acne. Acta Derm Venereal (Stockholm) 1972;52:406-410.
5. Prottey C, George D, Leech Rw, et al. The mode of action of ethyl lactate as a treatment for acne. Br J Dermatol 1984;110:475-485.
6. George D, Prottey C, Black JG, et al. Ethyl lactate as treatment for acne. Br J Dermatol 1983;108:228.
7. Liani L, Pasricha JS. Evaluation of topical erythromycin and topical lactate with or without systemic ketoconazole in acne vulgaris. Indian J Dermatol Venereal Leprol 1992;58:323-327.

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Ammonium Lactate Cream Approved To Treat Xerosis, Bioequivalent to Lac-Hydrin

Taro’s ammonium lactate cream is bioequivalent to Bristol-Myers Squibb’s Lac-Hydrin® cream. Ammonium lactate cream is a prescription product used for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions. According to industry sources, 2002 U.S. sales of ammonium lactate cream products were approximately $34.5 million.

“Ammonium lactate cream gives physicians and patients an affordable option in treating skin disorders such as xerosis and ichthyosis vulgaris,” said Barrie Levitt, M.D., Chairman of the Company. “This new product further enhances Taro’s position as a leading supplier of topical dermatological products.”

Currently, Taro has 23 filings at the FDA: 21 ANDAs, including one tentative approval, one unique supplemental ANDA, and a New Drug Application related to the Company’s NonSpil(TM) liquid drug delivery system. In addition, the Company has multiple regulatory filings in Canada, Israel and other countries around the world.

Taro is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.

For further information on Taro Pharmaceutical Industries Ltd., please visit the Company’s website at

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