Label: AQUAPHOR ORIGINAL- 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 November 14, 2022

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  • ACTIVE INGREDIENT

    Petrolatum 41%

  • PURPOSE

    Purpose

    Skin Protectant Ointment

  • INDICATIONS & 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

  • WARNINGS

    Warnings

    For external use only

    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 INGREDIENT

    Mineral Oil, Ceresin, Lanolin Alcohol

  • QUESTIONS

    Questions or comments?
    1-800-227-4703

  • DOSAGE & ADMINISTRATION

    Directions

    Apply as needed

  • PRINCIPAL DISPLAY PANEL

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    Aquaphor Original Ointment

    Severly Dry Skin Treatment

    Clinically proven to restore smooth, healthy skin

    Preservative and Fragrance Free

    Skin Protectant

    Dermatologist recommended

    For the pharmacist: Aquaphor provides an ideal base for compounding smooth, stable emulsions.

    It is highly miscible with aqueous solutions as well as oil-based substances.

  • INGREDIENTS AND APPEARANCE
    AQUAPHOR ORIGINAL 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:10356-100-37396 g in 1 JAR; Type 0: Not a Combination Product06/01/1975
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/1975
    Labeler - Beiersdorf Inc (001177906)
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