HYDROPHOR (PETROLATUM) OINTMENT [GERITREX LLC]

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HYDROPHOR (PETROLATUM) OINTMENT [GERITREX LLC]
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NDC 54162-500-01
Set ID 00d30389-5f92-45fa-90cc-c263451f45a6
Category HUMAN OTC DRUG LABEL
Packager Geritrex LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • Drug Facts

    Active Ingredients: Petrolatum 42%
    Purpose: Skin protectant

  • Uses

    • Rehydrates dry, chapped or chafed
    skin.
    • May be used alone as a skin lubricant
    or protectant.

  • Directions

    Apply generously to affected areas
    or as directed by your physician.

  • DOSAGE & ADMINISTRATION

    Apply generously to affected area

  • Warnings

    For External Use Only.
    When using this product:
    • Avoid contact with eyes.
    • If the condition worsens,
    discontinue use and contact a
    physician.

  • Inactive Ingredient

    Ceresin, Lanolin Alcohol,
    Microcrystalline Wax, Mineral Oil,
    Phenoxyethanol

  • STORAGE AND HANDLING

    Store at room temperature (59°F-86°F).

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    HP16C

  • INGREDIENTS AND APPEARANCE
    HYDROPHOR 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM42 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-500-01454 g in 1 JAR; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/31/2015
    Labeler - Geritrex LLC (112796248)
    Registrant - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex LLC112796248manufacture(54162-500)
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