Label: AMMONIUM LACTATE lotion

Rx only

For Dermatologic Use Only.
Not for Ophthalmic, Oral or Intravaginal Use.

*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:

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 vitrostudy of percutaneous absorption of Ammonium Lactate Lotion using human cadaver skin indicates that approximately 5.8% of the material was absorbed after 68 hours.

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.

Sun exposure to areas of the skin treated with Ammonium Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONSsection). The use of Ammonium Lactate Lotion should be discontinued if hypersensitivity is observed.

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).

The oral administration of Ammonium Lactate Lotion to rats and mice showed this drug to be practically non-toxic (LD 50>15 mL/kg).

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

225 g (NDC 51672-1300-5) plastic bottle and 400 g (NDC 51672-1300-9) plastic bottle.

Mfd. by:
Taro Pharmaceuticals Inc.
Brampton, Ontario,
Canada L6T 1C1

Dist. by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532
Revised: July 2022

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