AMMONIUM LACTATE lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMMONIUM LACTATE (UNII: 67M901L9NQ) (LACTIC ACID - UNII:33X04XA5AT)

Available from:

Nnodum Pharmaceuticals

INN (International Name):

AMMONIUM LACTATE

Composition:

AMMONIUM LACTATE 17 g in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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. Ammonium Lactate Lotion is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

Product summary:

Ammonium lactate Lotion, 12% is available in a 225g (NDC # 63044-484-09) plastic bottle. 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

AMMONIUM LACTATE - AMMONIUM LACTATE LOTION
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._
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AMMONIUM LACTATE LOTION
NDC # 63044-484-09
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
DESCRIPTION
Ammonium Lactate Lotion, 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 Lotion, 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
Lotion using human cadaver skin
indicates that approximately 5.8% of the material was absorbed after
68 hours.
INDICATIONS AND 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.
CONTRAINDICATIONS
Ammonium Lactate Lotion 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
Lotion, 12% should be minimized or
avoided (see PRECAUTIONS). T