Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
AMMONIUM LACTATE (UNII: 67M901L9NQ) (LACTIC ACID - UNII:33X04XA5AT)
Nnodum Pharmaceuticals
AMMONIUM LACTATE
AMMONIUM LACTATE 17 g in 1 g
TOPICAL
OTC DRUG
Ammonium Lactate Cream is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions. Ammonium Lactate Cream is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
Ammonium lactate Cream, 12% is available in a 140g (NDC # 63044-404-20) plastic tube. Store at controlled room temperature 15° C - 30° C (59° F - 86° F). Manufactured for: Nnodum Pharmaceuticals Cincinnati, Ohio 45229 By: EMS Contract Manufacturing Revised January 2008 Ammonium lactate Lotion
OTC monograph not final
AMMONIUM LACTATE - AMMONIUM LACTATE CREAM NNODUM PHARMACEUTICALS _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- AMMONIUM LACTATE CREAM 63044-404-20 FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. DESCRIPTION Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. INGREDIENTS: Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, light mineral oil, magnesium aluminum silicate, methyl and propyl parabens, Carbomer 940, PEG-100 stearate, polysorbate 85, triethanolamine, propylene glycol, Petrolatum and Sodium PCA, stearic acid and water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: CLINICAL PHARMACOLOGY Lactic acid is an alpha-hydroxy acid. It is a normal constituent of tissues and blood. The alpha-hydroxy acids (and their salts) may act as humectants when applied to the skin. This property may influence hydration of the stratum corneum. In addition, lactic acid, when applied to the skin, may act to decrease corneocyte cohesion. The mechanism(s) by which this is accomplished is not yet known. An _in vitro_ study of percutaneous absorption of Ammonium Lactate Cream using human cadaver skin indicates that approximately 5.8% of the material was absorbed after 68 hours. INDICATIONS AND USAGE Ammonium Lactate Cream is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions. CONTRAINDICATIONS Ammonium Lactate Cream is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients. WARNING Sun exposure to areas of the skin treated with Ammonium lactate Cream, 12% should be minimized or avoided (see PRECAUTIONS). The use of Ammo Прочитајте комплетан документ