Label: CAREONE HEALING- 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 September 30, 2013

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  • Active ingredient

    Petrolatum 41%

  • Purpose

    Skin protectant (ointment)

  • Keep Out of Reach of Children

  • Uses

    • temporarily protects and helps relieve chapped or cracked skin and lips
    • temporarily protects minor:

      cuts

      scrapes

      burns

    • helps protect from the drying effects of wind and cold weather
  • 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

  • Other information

    Do not use if inner seal is broken or missing

  • Inactive ingredients

    mineral oil, ceresin, lanolin, alcohol, glycerin, panthenol (pro-viatmin B5), bisabolol.

  • Package/Label Principal Display Panel

    CAREONE
    healing ointment

    advanced treatment for cracked, dry or irritated skin

    *Compare to Eucerin® Aquaphor® Healing Ointment Ingredients

    NET WT 14 OZ (396 g)

    • Skin Protectant
    • Non-Irritating
    • Fragrance-Free
    • Clinically proven
    • Restores smooth, healthy skin

    *This product is not manufactured or distributed by Beiersdorf Inc. owner of the registered trademark Eucerin® Aquaphor®.

    DISTRIBUTED BY FOODHOLD, U.S.A., LLC
    LANDOVER, MD 20785 1-877-846-9949
    © 2013 S&S Brands, LLC

    MADE IN ISRAEL

    Quality guaranteed or your money back.

    0D541 D4 F1

    Jar Label

    Jar Label

  • INGREDIENTS AND APPEARANCE
    CAREONE HEALING 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-541
    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 (UNII: 7EV65EAW6H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-541-11396 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/15/2013
    Labeler - American Sales Company (809183973)
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