Your browser does not support JavaScript! ASSURED PAIN RELIEF HOT PATCH (MENTHOL, CAPSICUM OLEORESIN) PATCH [GREENBRIER INTERNATIONAL, INC.]
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ASSURED PAIN RELIEF HOT PATCH (menthol, capsicum oleoresin) patch
[GREENBRIER INTERNATIONAL, INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

Active ingredients                                                                         Purpose

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

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

Uses

Temporarily relieves minor pain associated with:

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

Warnings

For external use only

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

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

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 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

Distributed by:

Greenbrier International, Inc.

500 Volvo Parkway

Chesapeake, VA 23320

Made in Korea

image of carton label

ASSURED PAIN RELIEF HOT PATCH  
menthol, capsicum oleoresin patch
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:33992-1889
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL30 mg
CAPSAICIN (CAPSAICIN) CAPSAICIN8.3 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALUMINUM HYDROXIDE 
EDETATE DISODIUM 
GELATIN 
KAOLIN 
METHYLPARABEN 
POLYSORBATE 80 
SORBITOL 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
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)

Revised: 3/2013
 
GREENBRIER INTERNATIONAL, INC.

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