Label: HYDROPHOR- petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 8, 2016

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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

    Label of Jar

  • 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:54162-500-02100 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/31/2015
    Labeler - Geritrex LLC (112796248)
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