Label: CARE ONE PAIN RELIEF- camphor (synthetic), menthol and methyl salicylate cream

  • NDC Code(s): 41520-049-16, 41520-049-26
  • Packager: American Sales Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 11/11

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

  • Active ingredient

    Camphor 4%

    Menthol 10%

    Methyl salicylate 30%

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  • Purpose

    Topical analgesic

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  • Uses

    temporarily relieves the minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
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  • Warnings

    For external use only

    Do not use

    other than as directed

    When using this product

    • avoid contact with the eyes or mucous membranes
    • do not apply to wounds or damaged skin
    • do not bandage tightly
    • do not use with a heating pad

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • redness is present or excessive skin irritation develops

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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  • Directions

    • use only as directed
    • adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
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  • Other information

    store at 20°-25°C (68°-77°F)

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  • Inactive ingredients

    carbomer homopolymer type C, edetate disodium, glyceryl monostearate, lanolin anhydrous, PEG-100 stearate, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the Active Ingredients in Ultra Strength Bengay®

    Fast Relief from Minor Arthritis, Backache, Muscle & Joint Pain

    ULTRA STRENGTH

    PAIN RELIEF CREAM

    GREASELESS

    PAIN RELIEVING CREAM

    Pain Relief Cream Carton Image 1

    Pain Relief Cream Carton Image 1

    Pain Relief Cream Carton Image 2

    Pain Relief Cream Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    CARE ONE PAIN RELIEF 
    camphor, menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-049
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 4 g  in 100 g
    MENTHOL (MENTHOL) MENTHOL 10 g  in 100 g
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 30 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    EDETATE DISODIUM  
    GLYCERYL MONOSTEARATE  
    POLYSORBATE 80  
    POTASSIUM HYDROXIDE  
    WATER  
    STEARIC ACID  
    TROLAMINE  
    CARBOMER HOMOPOLYMER TYPE C  
    PEG-100 STEARATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-049-16 1 in 1 CARTON
    1 57 g in 1 TUBE
    2 NDC:41520-049-26 1 in 1 CARTON
    2 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/01/2008
    Labeler - American Sales Company (809183973)
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