Label: BABY CARE 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)

    Treatment or prevention of diaper rash

  • Keep Out of Reach of Children

  • Uses

    • temporarily protects and helps relive 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

    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-vitamin B5), bisabolol.

  • Package/Label Principal Display Panel

    Cottontails baby care

    healing ointment

    *Compare to Eucerin® Aquaphor ® Baby Healing Ointment Ingredients

    NET WT 14 OZ (396g)

    advanced treatment for cracked, dry or irritated skin

    skin protectant

    non-irritating

    restores healthy skin

    Take care of your little one, from the top of their head to their tiny little toes, with Cottontails©.

    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 Ahold Licensing, Sarl
    MADE IN ISRAEL
    Quality guaranteed or your money back.
    BD541 D4 F1

    Jar Label

    Jar Label

  • INGREDIENTS AND APPEARANCE
    BABY CARE HEALING 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-540
    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)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-540-11396 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/13/2013
    Labeler - American Sales Company (809183973)
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