Label: SHOPKO 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 April 8, 2014

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  • Active ingredient

    Petrolatum, 41%

  • Purpose

    Skin Protectant (ointment)

  • 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
  • Directions

    •
    apply as needed
  • 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.
  • Other information

    •
    Store at room temperature.
  • Inactive ingredients

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

  • Package/Label Principal Display Panel - Carton Label

    SHOPKO®

    Healing Ointment
    Advanced Therapy
    For Dry, Cracked Skin

    NET WT 3.5 OZ (99 g)

    *Compare to active ingredients of Aquaphor® Healing Ointment

    SHOPKO®
    Satisfaction Guaranteed

    By Refund or Exchange

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

    Distributed by Shopko Stores Operating Co., LLC
    700 Pilgrim Way, Green Bay, WI 54307
    ©2014 Shopko Stores
    Operating Co., LLC

    Manufactured in Israel
    0D523 8C F1

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    SHOPKO HEALING 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-523
    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 ALCOHOLS (UNII: 884C3FA9HE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-523-1299 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/01/2014
    Labeler - Shopko Stores Operating Co., LLC (023252638)
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