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

  • NDC Code(s): 41520-976-03
  • 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 immediately. Do not induce vomiting before contacting a Poison Control Center.

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  • Uses

    Helps prevent and temporarily protect dry and chapped lips.

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  • 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.

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  • Directions

    Apply liberally and evenly. Reapply as needed.

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  • Inactive Ingredients

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

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  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    CARE ONE MEDICATED LIP BALM IN A POT 
    petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-976
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 43.75 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WHITE WAX 15.65 mg  in 1 g
    MINERAL OIL 15.5 mg  in 1 g
    MICROCRYSTALLINE WAX 12 mg  in 1 g
    LANOLIN 8 mg  in 1 g
    3-BROMOCAMPHOR, (+/-)- 1.7 mg  in 1 g
    CARNAUBA WAX .85 mg  in 1 g
    COCOA BUTTER .70 mg  in 1 g
    MENTHOL .70 mg  in 1 g
    2-BUTANOYLOXYBENZOIC ACID .5 mg  in 1 g
    PHENOL 0.4 mg  in 1 g
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MENTHOL Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-976-03 1 g in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 03/12/2013
    Labeler - American Sales Company (809183973)
    Registrant - American Sales Company (809183973)
    Establishment
    Name Address ID/FEI Business Operations
    OraLabs 801824756 MANUFACTURE(41520-976), LABEL(41520-976)
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