Label: ASSURED PAIN RELIEF HOT PATCH- menthol, capsicum oleoresin 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 March 31, 2013

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

  • PURPOSE

    Uses

    Temporarily relieves minor pain associated with:

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

    Warnings

    For external use only

  • PREGNANCY OR BREAST FEEDING

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

  • 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
  • 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
  • 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.

  • 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
  • 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

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Greenbrier International, Inc.

    500 Volvo Parkway

    Chesapeake, VA 23320

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    ASSURED PAIN RELIEF HOT PATCH  
    menthol, capsicum oleoresin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1889
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN8.3 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN (UNII: 2G86QN327L)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITOL (UNII: 506T60A25R)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1889-21 in 1 BOX
    12 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/31/2013
    Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)