Label: SHOPKO MEDICATED LIP TREATMENT- camphor, phenol gel

  • 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 August 1, 2013

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  • Active ingredient

    Camphor (1.70%), Menthol (0.70%)

  • Purpose

    Analgesic, Anti-itch

  • Keep Out of Reach of Children

    If swallowed get medical help or contact a Poison Control Center right away.

  • Uses

    For the temporary relief of pain and itching associated with fever blisters and cold sores. Helps prevent and temporarily protects dry chapped 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. Keep out of reach of children: if swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    Apply liberally and evenly. Reapply as needed.

  • Inactive Ingredients

    Copernicia Cerifera (Carnauba) Wax, Flavor, Lanolin, Microcrystalline Wax, Mineral Oil, Ozokerite, Petrolatum, Phenol, Salicylic Acid, Theobroma Cacao (Cocoa) Seed Butter.

  • Package/Label Principal Display Panel

    Front and Back of Card - Shopko Lip Treatment
  • INGREDIENTS AND APPEARANCE
    SHOPKO MEDICATED LIP TREATMENT 
    camphor, phenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-735
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.700 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.700 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 1.053 mg  in 1 g
    PHENOL (UNII: 339NCG44TV) 0.400 mg  in 1 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) 0.500 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) 83.947 mg  in 1 g
    CERESIN (UNII: Q1LS2UJO3A) 1.000 mg  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) 8.000 mg  in 1 g
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-735-041 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/15/2013
    Labeler - Shopko (023252638)
    Registrant - Shopko (023252638)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(37012-735) , LABEL(37012-735)
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