Ammonium Lactate
Lotion · Topical
Uses
Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.
Dosage and administration
Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
Contraindications
Ammonium Lactate Cream, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
Warnings
Sun exposure to areas of the skin treated with Ammonium Lactate Cream, 12% should be minimized or avoided (see PRECAUTIONS section). The use of Ammonium Lactate Cream, 12% should be discontinued if any hypersensitivity is observed.
Precautions
General For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded (for example, after shaving the legs). Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied. Information for Patients Patients using Ammonium Lactate Cream, 12% should receive the following information and instructions: This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with the eyes, lips, or mucous membranes. Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin. This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs). If the skin condition worsens with treatment, the medication should be promptly discontinued. Carcinogenesis, Mutagenesis, Impairment of Fertility The topical treatment of CD-1 mice with 12%, 21% or 30% ammonium lactate formulations for two years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% ammonium lactate cream enhanced the rate of ultraviolet light-induced skin tumor formation. The mutagenic potential of ammonium lactate cream was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative. In dermal Segment I and III studies with ammonium lactate cream there were no effects observed in fertility or pre- or post-natal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m 2 /day), approximately 0.4 times the human topical dose. Pregnancy Teratogenic effects Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m 2 /day in the rat and 7200 mg/m 2 /day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate cream. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ammonium Lactate Cream, 12% should be used during pregnancy only if clearly needed. Nursing Mothers Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ammonium Lactate Cream, 12% is administered to a nursing woman. Pediatric Use The safety and effectiveness of Ammonium Lactate Cream, 12% have been established in pediatric patients as young as 2 years old. Geriatric Use Clinical studies of Ammonium Lactate Cream, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.
Side effects
In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10 to 15% of patients. In addition, itching was reported in approximately 5% of patients. In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Pregnancy
Pregnancy Teratogenic effects Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m 2 /day in the rat and 7200 mg/m 2 /day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate cream. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ammonium Lactate Cream, 12% should be used during pregnancy only if clearly needed.
Pediatric use
Pediatric Use The safety and effectiveness of Ammonium Lactate Cream, 12% have been established in pediatric patients as young as 2 years old.
Geriatric use
Geriatric Use Clinical studies of Ammonium Lactate Cream, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.
Description
DESCRIPTION * Ammonium Lactate Cream, 12% specially formulates 12% lactic acid, as ammonium lactate to provide a cream pH of 4.5 to 5.5. Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl monostearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, propylparaben, polyoxyethylene-100 stearate, polyoxyl 40 stearate, propylene glycol, purified water and for pH adjustment: lactic acid. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: Chemical Structure
How supplied
Ammonium Lactate Cream, 12% is available as follows: 1-140 gram laminate tube NDC 51672-1301-2 2-140 gram laminate tubes NDC 51672-1301-4 385 gram plastic bottle NDC 51672-1301-0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Patient information
Information for Patients Patients using Ammonium Lactate Cream, 12% should receive the following information and instructions: This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with the eyes, lips, or mucous membranes. Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin. This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs). If the skin condition worsens with treatment, the medication should be promptly discontinued.
Label text from the FDA structured product label by Sun Pharmaceutical Industries, Inc. (revised Aug 17, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Ammonium Lactate in 12 products
Ammonium Lactate NDC products (12)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-6587 | Ammonium Lactate 120 mg/g Lotion | A-S Medication Solutions | ANDA |
| 63629-8608 | Ammonium Lactate 12 g/100g Cream | Bryant Ranch Prepack | ANDA |
| 63629-8609 | Ammonium Lactate 12 g/100g Cream | Bryant Ranch Prepack | ANDA |
| 63629-8610 | Ammonium Lactate 12 g/100g Lotion | Bryant Ranch Prepack | ANDA |
| 63629-8611 | Ammonium Lactate 12 g/100g Lotion | Bryant Ranch Prepack | ANDA |
| 72162-1407 | Ammonium Lactate 12 g/100g Lotion | Bryant Ranch Prepack | ANDA |
| 72162-1413 | Ammonium Lactate 12 g/100g Cream | Bryant Ranch Prepack | ANDA |
| 45802-419 | Ammonium Lactate 12 g/100g Lotion | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 45802-493 | Ammonium Lactate 12 g/100g Cream | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 70518-3619 | Ammonium Lactate 120 mg/g Cream | REMEDYREPACK INC. | ANDA |
| 51672-1300 | Ammonium Lactate 120 mg/g Lotion | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-1301 | Ammonium Lactate 120 mg/g Cream | Sun Pharmaceutical Industries, Inc. | ANDA |
Frequently asked questions
What is Ammonium Lactate used for?
Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.
What are the side effects of Ammonium Lactate?
In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10 to 15% of patients. In addition, itching was reported in approximately 5% of patients. In controlled clinical trials of patients with… See the full label for the complete list.
Who makes Ammonium Lactate?
Ammonium Lactate is listed by 5 labelers in the FDA NDC directory, including A-S Medication Solutions, Bryant Ranch Prepack, Padagis Israel Pharmaceuticals Ltd, REMEDYREPACK INC..