Label: ASSURED PAIN RELIEF HOT MENTHOL- menthol patch

  • NDC Code(s): 33992-6156-3
  • Packager: Greenbrier International, Inc
  • 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 December 5, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredient                                                                     Purpose

    Menthol 30mg--------------------------------------------------------- Topical analgestic

    Capsicum extract (capsaicin) 8.3mg--------------------------------- Topical analgestic

  • PURPOSE

    Uses  Temporarily relieves minor pain associated with:

    • arthritis
    • simple backche
    • bursitis
    • tendonitis
    • muscle strains
    • music sprains
    • bruises
    • cramps
  • WARNINGS

    For external use only

    • If pregnant or breast feeding, ask a health professional before use.
  • WHEN USING

    When using this product

    • use as only 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 skin
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist more than 7 days or clear up and occur again within a few days
    • redness is present
    • skin irritation develops
    • do not apply to wounds or damanged skin
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of chidren.

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

  • INDICATIONS & USAGE

    Directions

    • Adults and children 12 years of age and older: apply to affected area no more than 3 to 4 times daily.
    • Children under 12 years of age: do not use, consult a doctor.
    • For easy application: partially peel back protective film and apply exposed film and apply exposed patch to site of pain.
    • Carefully remove remaining film while pressing patch to skin for secure adhesion.
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, tatanium dioxide, tocopherol acetate

    Release liner: polypropylene, non-woven material: polyester non-woven fabric

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY

    GREENBRIER INTERNATIONAL, INC.

    500 VOLVO PARKWAY

    CHESAPEAKE, VA 23320

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ASSURED PAIN RELIEF HOT MENTHOL 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-6156
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 100 mg
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN8.3 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-6156-32 in 1 CARTON10/17/2014
    130 mg in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/17/2014
    Labeler - Greenbrier International, Inc (610322518)