Label: GERI-HYDROLAC- ammonium lactate cream

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

Drug Label Information

Updated June 25, 2013

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  • Drug Facts

    Active Ingredient: Ammonium lactate 12%

    Purpose: Stimulates cell renewal for improved skin condition

  • Uses

    For mosturizing and softening dry scaly skin

  • Directions

    Apply to affected areas and rub in thoroughly, 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.

    Cautions: Irritation may occur on the face. Fair skinned individuals

    may experience mild stinging. Burning or peeling may occur on sensitive or irritated skin areas.

    If irritation occurs, Discontinue use immediately and consult a physcian for appropiate therapy.

  • Inactive Ingredient

    Water, Light mineral oil, Petrolatum, Peg 100 stearate, Propylene Glycol,
    Oleth 5, Glycerin, cetyl Alcohol, DMDM Hydantoin, Magnesium Aluminum silicate, Methyl and propyl paraben,
    Guarcel

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In the event of accidental ingestion contact a posion control center right away.

  • STORAGE AND HANDLING

    Store at room temperature (59'-86'F)

  • DOSAGE & ADMINISTRATION

    Twice daily or as directed by a physician

  • PRINCIPAL DISPLAY PANEL

    label of Tube

  • INGREDIENTS AND APPEARANCE
    GERI-HYDROLAC 
    ammonium lactate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-012
    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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LAURETH-4 (UNII: 6HQ855798J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GUAR GUM (UNII: E89I1637KE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-012-5050 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only06/25/2013
    Labeler - GERITREX CORP (112796248)
    Registrant - GERITREX CORP (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    GERITREX CORP112796248manufacture(54162-012)
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