Label: CARE ONE MEDICATED LIP BALM- petrolatum stick

  • NDC Code(s): 41520-975-02
  • Packager: American Sales Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Petrolatum

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  • Purpose

    Skin Protectant

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  • Keep Out of Reach of Children

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

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  • Uses

    Helps heal severely dry, chapped lips.

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  • Warnings

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

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  • Directions

    Apply to lips not more than 3 – 4 times daily. Children under six months of age: Ask doctor before use.

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  • 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

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  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    CARE ONE MEDICATED LIP BALM 
    petrolatum stick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-975
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 41 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CERESIN 16 mg  in 1 g
    APIS CERANA WORKER SECRETION 6 mg  in 1 g
    OLEYL ALCOHOL 6 mg  in 1 g
    ISOPROPYL MYRISTATE 5 mg  in 1 g
    OCTYLDODECANOL 9 mg  in 1 g
    LANOLIN 4 mg  in 1 g
    STEARYL ALCOHOL 3 mg  in 1 g
    CETYL ALCOHOL 3 mg  in 1 g
    LIGHT MINERAL OIL 3 mg  in 1 g
    MENTHOL .60 mg  in 1 g
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor MENTHOL Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-975-02 4.25 g in 1 CYLINDER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 03/11/2013
    Labeler - American Sales Company (809183973)
    Registrant - American Sales Company (809183973)
    Establishment
    Name Address ID/FEI Business Operations
    OraLabs 801824756 MANUFACTURE(41520-975), LABEL(41520-975)
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