Label: HEALING- 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 31, 2023

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  • Active ingredient

    Petrolatum 41%

  • Purpose

    Skin protectant (ointment)

  • Uses

    • temporarily protects minor: cuts, scrapes, burns
    • temporarily protects and helps releive chapped or cracked skin and lips
    • helps protects from the drying effects of wind and cold weather
  • Warnings

    For external use only

  • When using this product

    • do not get in 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 medial help or contact a Poison Control Center right away.

  • Directions

    • apply as needed
  • Inactive ingredients

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

  • Questions?

    Call 1-888-423-0139

  • Claims

    TopCARE beauty

    For dry, cracked or irritated skin

    Restores smmoth, healthy skin

    Fragrance-free - Hypoallergenic 

    Dermatologist tested

  • SPL UNCLASSIFIED SECTION

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

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    (C) TOPCO  VIJS0220  QUESTIONS? 1-888-423-0139   

    topcare@topco.com   www.topcarebrand.com

  • principal display panel

    TopCare

    beauty

    ADVANCED

    HEALING OINTMENT

    SKIN PROTECTANT

    Compare to Aquaphor*

    For dry & cracked skin

    Fragrance Free

    NET WT 14 OZ (396 g)

    image description

  • INGREDIENTS AND APPEARANCE
    HEALING 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-247
    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:36800-247-41396 g in 1 JAR; Type 0: Not a Combination Product11/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/01/2013
    Labeler - Topco Associates LLC (006935977)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(36800-247)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(36800-247)
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