Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 225 g (NDC 51672-1300-5) plastic bottle and 400 g (NDC 51672-1300-9) plastic bottle. Store between 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - 225 g Bottle Label NDC 51672-1300-5 225 g Ammonium Lactate Lotion 12%* CONTAINS: *Ammonium lactate equivalent to 12% lactic acid, cetyl alcohol, glycerin, glyceryl monostearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, polyoxyethylene 100 stearate, polyoxyl stearate type II, propylene glycol, propylparaben, purified water, and for pH adjustment: lactic acid. For Dermatologic Use Only. Not for Ophthalmic, Oral or Intravaginal Use. See package insert for full prescribing information. Store at controlled room temperature 20° to 25°C (68° to 77°F). For lot number and expiry date see below. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 5230699 0722 Rx only TARO PRINCIPAL DISPLAY PANEL - 225 g Bottle Label
- HOW SUPPLIED 225 g (NDC 51672-1300-5) plastic bottle and 400 g (NDC 51672-1300-9) plastic bottle. Store between 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
- PRINCIPAL DISPLAY PANEL - 225 g Bottle Label NDC 51672-1300-5 225 g Ammonium Lactate Lotion 12%* CONTAINS: *Ammonium lactate equivalent to 12% lactic acid, cetyl alcohol, glycerin, glyceryl monostearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, polyoxyethylene 100 stearate, polyoxyl stearate type II, propylene glycol, propylparaben, purified water, and for pH adjustment: lactic acid. For Dermatologic Use Only. Not for Ophthalmic, Oral or Intravaginal Use. See package insert for full prescribing information. Store at controlled room temperature 20° to 25°C (68° to 77°F). For lot number and expiry date see below. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 5230699 0722 Rx only TARO PRINCIPAL DISPLAY PANEL - 225 g Bottle Label
Overview
*Ammonium Lactate Lotion, 12% specially formulates 12% lactic acid, as ammonium lactate to provide a lotion pH of 4.5 to 5.5. Ammonium Lactate Lotion also contains cetyl alcohol, glycerin, glyceryl monostearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, polyoxyethylene 100 stearate, polyoxyl stearate type II, propylene glycol, propylparaben, 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
Indications & Usage
Ammonium Lactate Lotion is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.
Dosage & Administration
Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
Warnings & Precautions
WARNINGS Sun exposure to areas of the skin treated with Ammonium Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS section). The use of Ammonium Lactate Lotion should be discontinued if hypersensitivity is observed.
Contraindications
Ammonium Lactate Lotion is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
Adverse Reactions
The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).
Storage & Handling
Store between 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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