Label: SHOPKO MEDICATED LIP BALM- petrolatum stick

  • 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 July 24, 2013

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  • Active ingredient

    Petrolatum

  • Purpose

    Skin Protectant

  • Keep Out of Reach of Children

    If swallowed, contact a Poison Control Center.

  • Uses

    Helps prevent and temporarily protects chapped or windburned lips.

  • Warnings

    For external use only.

    When using this product: avoid contact with eyes. Rinse with water to remove. Stop use and ask a doctor if :rash or irritation develops and lasts for more than 7 days. .

  • Directions

    Apply liberally and evenly as needed. Children under 2 years of age: ask doctor before use.

  • Inactive Ingredients

    Beeswax, Camphor, Cetyl Alcohol, Flavor, Ispropyl Myristate, Lanolin, Menthol, Methylparaben, Mineral Oil, Octyldodecanol, Oleyl Alcohol, Ozokerite, Phenol, Phenyl Trimethicone, Propylparaben, Stearyl Alcohol, Water

  • Package/Label Principal Display Panel

    Shopko Front and Back Card
  • INGREDIENTS AND APPEARANCE
    SHOPKO MEDICATED LIP BALM 
    petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-737
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM41 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A) 16 mg  in 1 g
    APIS CERANA WORKER SECRETION (UNII: PRG8653U8K) 6 mg  in 1 g
    OLEYL ALCOHOL (UNII: 172F2WN8DV) 6 mg  in 1 g
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 5 mg  in 1 g
    OCTYLDODECANOL (UNII: 461N1O614Y) 9 mg  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) 4 mg  in 1 g
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 3 mg  in 1 g
    CETYL ALCOHOL (UNII: 936JST6JCN) 3 mg  in 1 g
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 3 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) .60 mg  in 1 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-737-024.25 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/11/2013
    Labeler - Shopko (023252638)
    Registrant - Shopko (023252638)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(37012-737) , LABEL(37012-737)
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