Label: MEDPURA AMMONIUM LACTATE CREAM-

  • Category: COSMETIC
  • DEA Schedule: None
  • Marketing Status: Cosmetic

Drug Label Information

Updated November 30, 2024

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  • SPL UNCLASSIFIED SECTION

    Description: Ammonium Lactate 12% Moisturizing Cream 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) 225-6999

    Manufactured for:

    Akron Pharma, Inc.
    Fairfield, NJ-07004
    www.akronphanna.com

  • PRINCIPAL DISPLAY PANEL

    Cream

  • INGREDIENTS AND APPEARANCE
    MEDPURA AMMONIUM LACTATE CREAM 
    moisturizing [skin care preparations (creams, lotions, powder, and sprays)]
    Product Information
    Product TypeCOSMETICItem Code (Source)371399049445
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRAMMONIUM LACTATE (UNII: 67M901L9NQ) 12 g  in 100 g
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRGLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    INGRHYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    INGRLACTIC ACID (UNII: 33X04XA5AT)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGRMAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRPEG-40 (UNII: HAF0412YIT)  
    INGRHYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRLAURETH-4 (UNII: 6HQ855798J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1371399049445140 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    cosmetic11/22/2024
    Labeler - Akron Pharma Inc. (067878881)