Label: ASSURED PAIN RELIEF HOT PATCH  - menthol and capsaicin patch 

  • NDC Code(s): 33992-1889-2
  • Packager: GREENBRIER INTERNATIONAL, INC.
  • 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 03/13

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

  • ACTIVE INGREDIENT

    Active ingredients                                                                         Purpose

    Menthol 30mg...............................................................................Topical Analgesic

    Capsicum Extract (capsaicin) 8.3mg...............................................Topical Analgesic

    Close
  • PURPOSE

    Uses

    Temporarily relieves minor pain associated with:

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

    Warnings

    For external use only

    Close
  • PREGNANCY OR BREAST FEEDING

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

    Close
  • 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 skin
    Close
  • 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
    Close
  • 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.

    Close
  • INDICATIONS & USAGE

    Directions

    • Adults and 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: do not use, consult a doctor
    • For easy application: 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
    • Store unused patch in pouch.  Reseal pouch after opening
    Close
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera, aluminum hydroxide, disodium EDTA, gelatin, kaolin, methacrylic acid copolymer, methylparaben, polysorbate 80, sorbitan monostearate, sorbitol solution, tartaric acid, titanium dioxide, tocopheryl acetate (vitamin E), water

    Close
  • DOSAGE & ADMINISTRATION

    Distributed by:

    Greenbrier International, Inc.

    500 Volvo Parkway

    Chesapeake, VA 23320

    Made in Korea

    Close
  • INGREDIENTS AND APPEARANCE
    ASSURED PAIN RELIEF HOT PATCH  
    menthol, capsicum oleoresin patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:33992-1889
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 30 mg
    CAPSAICIN (CAPSAICIN) CAPSAICIN 8.3 mg
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    ALUMINUM HYDROXIDE  
    EDETATE DISODIUM  
    GELATIN  
    KAOLIN  
    METHYLPARABEN  
    POLYSORBATE 80  
    SORBITOL  
    TARTARIC ACID  
    TITANIUM DIOXIDE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33992-1889-2 1 in 1 BOX
    1 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/31/2013
    Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
    Close