Label: GERI-HYDROLAC- ammonium lactate lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated May 10, 2013

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  • Drug Facts

    Active Ingredient Ammonium Lactate 12%

    Purpose: Stimulates cell renewal for improved skin conditon

  • Uses

    For moisturizing and softening dry skin

  • Directions

    Apply thin layer to the skin twice daily or as directed by a physician

  • Warnings

    FOR EXTERNAL USE ONLY

    When using this product:

    Avoid contact with eyes, lips or mucous membranes

    DO NOT apply over deep or punctured wounds, infections or lacerations.

    Skin may become more sensitive to the sun, mild stinging, burning or peeling

    may occur. Use sunscreen or avoid exposure.

    If irritation occurs. Discontinue use immediately and consult physician for appropiate therapy. If pregnant or nursing consult

    your physician or pharmacist

  • INACTIVE INGREDIENT

    water, Mineral oil, Glycerin, Sorbitan sesquioleate, Cetyl alcohol, Peg-100 stearate, Oleth-5, DMDM Hydantoin,

    Magnesium Aluminum silicate, Propylene glycol, propyl and methyl parabens, Lemon oil

  • Keep out of reach of children

    In the event of accidental ingestion contact a Posion Control Center right away

  • DOSAGE & ADMINISTRATION

    Twice daily or as directed by a physician

  • PRINCIPAL DISPLAY PANEL

    Label of Bottle

  • INGREDIENTS AND APPEARANCE
    GERI-HYDROLAC 
    ammonium lactate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIUM LACTATE (UNII: 67M901L9NQ) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OLETH-5 (UNII: 1GH33785AY)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LEMON OIL (UNII: I9GRO824LL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-013-01100 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only05/10/2013
    Labeler - GERITREX CORP (112796248)
    Registrant - GERITREX CORP (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    GERITREX CORP112796248manufacture(54162-013)
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