Label: PERSONAL CARE EXTRA STRENGTH COLD HOT - menthol patch 

  • NDC Code(s): 29500-9083-3
  • Packager: PERSONAL CARE PRODUCTS, LLC
  • 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 09/12

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

  • ACTIVE INGREDIENT

    Active ingredient                                                                    Purpose

    Menthol 5% ..........................................................................Topical analgesic

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  • PURPOSE

    Uses for the temporary relief of minor aches and pains associated with:

    • simple backache
    • muscle strains
    • muscle sprains
    • cramps
    • bursitis
    • arthritis
    • bruises
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  • WARNINGS

    Warnings

    For external use only

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  • WHEN USING


    When using this product

    • use only as directed
    • do not apply to wounds, damaged, or sensitive skin
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
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  • STOP USE

    Stop use and ask doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
    • redness is present
    • skin irritation develops
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

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  • INDICATIONS & USAGE

    Directions

    adults and children 12 years of age and older

    • partially peel back protective film and apply exposed patch to site of pain
    • carefully remove remaining film while pressing patch to skin for secure adhesion
    • repeat as necessary, but not more than 3 to 4 times daily
    children under 12 years of age consult a doctor
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  • STORAGE AND HANDLING

    Other information

    Store at 68o to 77oF (20o to 25oC)

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  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monsterarate, polysorbate 80,

    polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate (Vitamin E).

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  • DOSAGE & ADMINISTRATION

    Distributed by:

    PERSONAL CARE PRODUCTS, LLC.

    Bingham Farms, MI 48025-3463

    Made in China

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  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

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  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE EXTRA STRENGTH COLD HOT  
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:29500-9083
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    ALUMINUM HYDROXIDE  
    BUTYLATED HYDROXYTOLUENE  
    CASTOR OIL  
    EDETATE DISODIUM  
    GELATIN  
    GLYCERIN  
    ISOPROPYL MYRISTATE  
    KAOLIN  
    METHYLPARABEN  
    POLYSORBATE 80  
    POLYVINYL ALCOHOL  
    WATER  
    MAGNESIUM ALUMINOMETASILICATE TYPE I-A  
    PEG-120 Stearate  
    povidone K90  
    sodium polyacrylate (2500000 MW)  
    tartaric acid  
    titanium dioxide  
    .alpha.-tocopherol acetate  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:29500-9083-3 1 in 1 CARTON
    1 2 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/20/2011
    Labeler - PERSONAL CARE PRODUCTS, LLC (966155082)
    Registrant - UNITED EXCHANGE CORP (840130579)
    Establishment
    Name Address ID/FEI Business Operations
    PLANET (SUZHOU) MEDICAL PRODUCTS CO., LTD 528194366 manufacture(29500-9083)
    Establishment
    Name Address ID/FEI Business Operations
    Yongkang Bangli Medical Products Co Ltd 723738741 manufacture(29500-9083)
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