Label: HEALING FOR BABIES- petrolatum ointment

  • NDC Code(s): 41250-997-17, 41250-997-21
  • Packager: Meijer Distribution
  • 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 July 26, 2023

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  • Active ingredient

    Petrolatum 41%

  • Purpose

    Skin protectant

  • 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
    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only

  • 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
    • animal bites
    • serious burns
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply as needed
    • for diaper rash, change wet and soiled diapers promptly
    • cleanse the diaper area
    • allow to dry
    • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • Inactive ingredients

    mineral oil, ceresin, lanolin alcohol, panthenol, glycerin, bisabolol

  • Disclaimer

    *This product is not manufactured or distributed by Beiersdorf Inc., distributor of Aquaphor® Healing Ointment.

  • Claims

    †This product would not normally contain parabens

  • Adverse Reaction

    DISTRIBUTED BY

    MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

    Questions 1-888-593-0593

  • Principal display panel

    meijer

    baby healing

    ointment

    skin protectant

    helps treat & prevent diaper rash

    †paraben & phthalate free

    hypoallergenic

    Compare to Aquaphor® Healing Ointment*

    NET WT. 3 OZ (85 g)

    image description

  • INGREDIENTS AND APPEARANCE
    HEALING FOR BABIES 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-997
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM410 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-997-2185 g in 1 TUBE; Type 0: Not a Combination Product02/19/2014
    2NDC:41250-997-1750 g in 1 TUBE; Type 1: Convenience Kit of Co-Package02/19/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/19/2014
    Labeler - Meijer Distribution (006959555)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41250-997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41250-997)
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