Label: HYDROPHOR ointment

  • NDC Code(s): 71399-5101-1, 71399-5101-2
  • Packager: Akron Pharma Inc.
  • 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 March 10, 2023

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  • Drug Facts

    Active Ingredient:

    Petrolatum 42%

    Purpose:

    Skin protectant

  • Uses

    temporarily protects minor:

    • cuts
    • scrapes
    • burns

    temporarily protects and helps relieve

    • chapped or cracked skin and lips
    • helps protects from the drying effects of wind and cold weather
  • Warnings

    For External Use Only.

  • INDICATIONS & USAGE

    When using this product:

    • do not get into eyes

    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

    Do not use on

    • deep or puncture wounds
    • animals bites
    • serious burns
  • KEEP OUT OF REACH OF CHILDREN

    • KEEP OUT OF REACH OF CHILDREN.
  • Directions

    • Apply as needed.
  • Inactive Ingredient

    Ceresin Wax, Lanolin, Mineral Oil, Paraffin Wax & Phenoxyethanol.

  • STORAGE AND HANDLING

    Other Information

    • do not use if inner seal is broken or missing

    Learn more at www.HydrophorUS.com

  • QUESTIONS

    Questions?

    Please Call 1(877) 225-6999

    Manufactured for:

    Akron Pharma, Inc.
    Fairfield, NJ 07004

    Manufactured in U.S.A

  • PRINCIPAL DISPLAY PANEL

    100gm

    454gm

  • INGREDIENTS AND APPEARANCE
    HYDROPHOR 
    hydrophor ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-5101
    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 (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-5101-1454 g in 1 JAR; Type 0: Not a Combination Product05/18/2021
    2NDC:71399-5101-2100 g in 1 JAR; Type 0: Not a Combination Product05/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/18/2021
    Labeler - Akron Pharma Inc. (067878881)
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