Label: AQUAPHOR- petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL

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 May 21, 2012

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  • ACTIVE INGREDIENTS

    Petrolatum 41%

  • PURPOSE

    Skin protectant ointment

  • INDICATIONS AND USAGE

    Uses
    • temporarily protects minor: • cuts • scrapes • burns
    • temporarily protects and helps relieve chapped or cracked
    skin and lips
    • helps protect from the drying effects of wind and
    cold weather

    Directions Apply as needed

  • WARNINGS

    For external use only

  • WHEN USING

    When using this product do not get into eyes

  • DO NOT USE

    Do not use on • deep or puncture wounds • animal bites
    • serious burns

  • STOP USE

    Stop use and ask a doctor if • condition worsens
    • symptoms last more than 7 days or clear up and occur
    again within a few days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical
    help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENTS

    Mineral Oil, Ceresin, Lanolin Alcohol

  • QUESTIONS

    Questions or comments? 1-800-227-4703

  • DIRECTIONS

    For the pharmacist: Aquaphor provides an ideal base for
    compounding smooth, stable emulsions. It is highly miscible
    with aqueous solutions and oil based substances.

  • PRINCIPAL DISPLAY PANEL


    Aquaphor
    OINTMENT

    Skin Protectant

    Ideal for Compounding

    Dermatologist Recommended

    SEVERELY DR Y SKIN TREATMENT
    Clinically proven to restore smooth, healthy skin

    NET WT
    14 oz
    396 g

    label


    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma        74146

  • INGREDIENTS AND APPEARANCE
    AQUAPHOR 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5870(NDC:10356-100)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum41 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5870-0396 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/28/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel