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Assured Pain Relief Hot Menthol

Dosage form: patch
Ingredients: MENTHOL 30mg in 100mg, CAPSAICIN 8.3mg in 100mg
Labeler: Greenbrier International, Inc
NDC Code: 33992-6156

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.

Active Ingredient                                                                     Purpose

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

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

Uses  Temporarily relieves minor pain associated with:

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

For external use only

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

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 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 chidren.

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 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 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

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

MADE IN KOREA

ASSURED PAIN RELIEF HOT MENTHOL 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-6156
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL30 mg  in 100 mg
CAPSAICIN (CAPSAICIN) CAPSAICIN8.3 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALUMINUM HYDROXIDE 
CASTOR OIL 
EDETATE DISODIUM 
GELATIN 
GLYCERIN 
ISOPROPYL MYRISTATE 
KAOLIN 
MAGNESIUM ALUMINUM SILICATE 
METHYLPARABEN 
POLYETHYLENE GLYCOL 1000 
POLYSORBATE 80 
POLYVINYL ALCOHOL 
water 
SODIUM POLYACRYLATE (8000 MW) 
TARTARIC ACID 
TITANIUM DIOXIDE 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:33992-6156-32 POUCH in 1 CARTON
130 mg in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/17/2014
Labeler - Greenbrier International, Inc (610322518)

Revised: 10/2014
 
Greenbrier International, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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