Label: MEDICATED PAIN RELIEF HOT- menthol, capsicum extract 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 July 1, 2019

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  • Active ingredients

    L-Menthol 0.4%

    Capsicum Extract (0.002% of Capsaicin)

  • Purposes

    Topical analgesic

    Topical analgesic

  • Uses

    Temporarily relieves minor pain associated with:

    • arthritis
    • muscle strains
    • simple backache
    • bursitis
    • cramps
    • tendonitis
    • muscle sprains
    • bruises
  • Warnings

    For external use only

    When using this product

    • use only as directed
    • do not bandage tightly
    • do not use a heating pad
    • avoid contact with eyes and mucous membrane
    • do not apply to wounds or damaged skin
    • do not use if you are allergic to any ingredients of this product

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding,

    ask a health professional before use

    Keep out of reach of children.

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

  • Directions

    Adults and children 12 years of age and older: Clean and dry affected area. Remove backing film and apply not more than 3 to 4 times daily.

    Children under 12 years of age: Consult a physician.

  • Other information

    store at 20° to 25°C (68° to 77°F)

  • Inactive ingredients

    Purified water, Glycerin, Disodium edetate, Tartaric acid, Gelatine, Polyvinyl alcohol, Sodium polyacrylate, Vitamin E acetate, Aloe vera

  • Package label

    image of carton

  • INGREDIENTS AND APPEARANCE
    MEDICATED PAIN RELIEF HOT 
    menthol, capsicum extract patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0226
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL46.92 mg
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TARTARIC ACID (UNII: W4888I119H)  
    GELATIN (UNII: 2G86QN327L)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0226-21 in 1 CARTON09/16/2011
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:67510-0226-41 in 1 CARTON09/16/2011
    24 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/16/2011
    Labeler - Kareway Product, Inc. (121840057)
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