Label: CARE ONE MEDICATED LIP BALM IN A POT- petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL

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 March 11, 2013

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  • Active ingredient

    Petrolatum

  • Purpose

    Skin Protectant

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center immediately. Do not induce vomiting before contacting a Poison Control Center.

  • Uses

    Helps prevent and temporarily protect dry and chapped lips.

  • Warnings

    For external use only: When using this product: avoid contact with eyes. Rinse with water to remove. Stop use and consult a doctor if: condition worsens or lasts more than 7 days. Do not induce vomiting before contacting a Poison Control Center. For adults and children over 2 years of age.

  • Directions

    Apply liberally and evenly. Reapply as needed.

  • Inactive Ingredients

    Synthetic Beeswax, Mineral Oil, Microcrystalline Wax, Lanolin, Camphor, Copernicia Cerifera (Carnauba) Wax, Menthol, Theobroma Cacao (Cocoa) Seed Butter, Salicylic Acid, Phenol, Flavor

  • Package/Label Principal Display Panel

    Care One Medicated Lip Balm Pot Card
  • INGREDIENTS AND APPEARANCE
    CARE ONE MEDICATED LIP BALM IN A POT 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-976
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM43.75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F) 15.65 mg  in 1 g
    MINERAL OIL (UNII: T5L8T28FGP) 15.5 mg  in 1 g
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 12 mg  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) 8 mg  in 1 g
    3-BROMOCAMPHOR, (+/-)- (UNII: NAY429URSN) 1.7 mg  in 1 g
    CARNAUBA WAX (UNII: R12CBM0EIZ) .85 mg  in 1 g
    COCOA BUTTER (UNII: 512OYT1CRR) .70 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) .70 mg  in 1 g
    2-BUTANOYLOXYBENZOIC ACID (UNII: K60ASJ7Z6N) .5 mg  in 1 g
    PHENOL (UNII: 339NCG44TV) 0.4 mg  in 1 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-976-031 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/12/2013
    Labeler - American Sales Company (809183973)
    Registrant - American Sales Company (809183973)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(41520-976) , LABEL(41520-976)
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