Label: MEDPURA AMMONIUM LACTATE LOTION-
- NDC Code(s): 371399014047, 371399014085
- Packager: Akron Pharma Inc.
- Category: COSMETIC
- DEA Schedule: None
- Marketing Status: Cosmetic
Drug Label Information
Updated December 1, 2024
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SPL UNCLASSIFIED SECTION
Description: Ammonium Lactate 12% Moisturizing Lotion helps hydrate, soften and exfoliate dry, rough skin. This skin smoothing cream is specially formulated with 12% lactic acid neutralized with ammonium hydroxide for a pH of 4.5 - 5.5.
Lactic acid is an alpha hydroxy acid and a natural humectant for the skin.
Directions: For best results, apply to dry skin twice a day, or as directed by a doctor.
Caution: For external use only. Keep out of reach of children. Avoid contact with the eyes, lips and mucus membranes. Irritation
may occur when used on the face. If irritation or sensitivity occurs, discontinue use.Ingredients: Ammonium Hydroxide Solution, Cetyl Alcohol, Glycerin, GMS & PEG 100 Stearate, Hydroxyethyl Cellulose, Lactic Acid,
Light Mineral Oil, Magnesium Aluminum Silicate, Methyl Paraben, PEG 40 Hydrogenated Castor oil, Propylene Glycol, Propyl Paraben, PurifiedWater, 2-dodecoxyethanol (Laureth-4).Other information: Store at 68°- 77°F (20°- 25°C).
Avoid excessive heat.
For lot number and expiration date, see crimp of the tube
Questions or comments? Please call 1 (877) 225-6999Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ-07004
www.akronphanna.com - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEDPURA AMMONIUM LACTATE LOTION
moisturizing [skin care preparations (creams, lotions, powder, and sprays)]Product Information Product Type COSMETIC Item Code (Source) 3713990104085 Other Ingredients Ingredient Kind Ingredient Name Quantity INGR AMMONIUM LACTATE (UNII: 67M901L9NQ) 12 g in 100 g INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) INGR HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) INGR LACTIC ACID (UNII: 33X04XA5AT) INGR MINERAL OIL (UNII: T5L8T28FGP) INGR MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PEG-40 (UNII: HAF0412YIT) INGR HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR WATER (UNII: 059QF0KO0R) INGR LAURETH-4 (UNII: 6HQ855798J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 371399014085 225 g in 1 PACKAGE 2 371399014047 400 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date cosmetic 11/22/2024 Labeler - Akron Pharma Inc. (067878881)