Label: MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY- menthol patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 February 3, 2017

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

    Temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • bursitis
    • tendonitis
    • muscle strains
    • muscle sprains
    • bruises
    • cramps
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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 bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skins

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  • STOP USE

    Stop use and ask a doctor if

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

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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:
    • remove backing from patch by grasping both ends firmly and gently pulling until backing seperates in middle
    • carefully remove backing from patch
    • apply one patch to affected area
    • wear one patch up to 8 hours
    • repeat as necessary, but no more than 4 times daily

    children 12 years or younger:

    • consult a doctor
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  • STORAGE AND HANDLING

    Other information

    • store at room temperature, not to exceed 86°F (30°C)
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  • INACTIVE INGREDIENT

    Inactive ingredients 1,3-butlene glycol, aloe vera, BHT, d-sorbitol, disodium edetate, gelatin, glycerin, kaolin, liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate

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  • DOSAGE & ADMINISTRATION

    Distributed By:

    Major Pharmaceuticals

    17177 N Laurel Park Dr.

    Suite 233

    Livonia, MI 48150

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY 
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5694
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 750 mg
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SORBITOL (UNII: 506T60A25R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MAGALDRATE (UNII: 6V88E24N5T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-5694-01 1 in 1 PACKAGE 02/03/2017
    1 5 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/30/2013
    Labeler - Major Pharmaceuticals (191427277)
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