Label: CARE ONE MEDICATED LIP BALM- petrolatum stick

  • 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 right away.

  • Uses

    Helps heal severely dry, chapped lips.

  • Warnings

    Stop use and ask a doctor: if rash or irritation develops and lasts.

  • Directions

    Apply to lips not more than 3 – 4 times daily. Children under six months 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

    Care One Lip Balm Card
    Care One Lip Balm Label
  • INGREDIENTS AND APPEARANCE
    CARE ONE MEDICATED LIP BALM 
    petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-975
    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:41520-975-024.25 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/11/2013
    Labeler - American Sales Company (809183973)
    Registrant - American Sales Company (809183973)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(41520-975) , LABEL(41520-975)
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