Label: HEALING FOR BABIES- 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 23, 2023

If you are a consumer or patient please visit this version.

  • Active ingredient

    Petrolatum 41%

  • Purpose

    Skin Protectant

  • Use

    • 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

  • Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • when using this product

    • do not get into eyes
  • stop use and ask a doctor if

    • condition worsens
    • symptom last more than 7 days or clear up and occur again within a few days
  • 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

  • SPL UNCLASSIFIED SECTION

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

    100% Satisfaction Guaranteed!

    (888)309-9030

    DISTRIBUTED BY

    OLD EAST MAIN CO

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

  • principal display panel

    *Compare to Aquaphor Healing Ointment

    Gentle Steps

    baby healing ointment

    Skin Protectant

    Fragrance Free

    Helps treat & precvent diaper rash

    NET WT 3OZ (85 g)

    image description

  • principal display panel

    DG

    baby

    Healing

    Ointment

    for Babies

    Skin Protectant

    Compare to

    Aquaphor Healing

    Ointment

    • Hypoallergenic
    • For irritated, dry or cracked skin
    • Dermatologist & Pediatrician tested
    • Helps treat and prevent diaper rash

    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:55910-180
    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:55910-180-2185 g in 1 TUBE; Type 0: Not a Combination Product03/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2012
    Labeler - OLD EAST MAIN CO (068331990)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-180)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-180)