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Assured Extra Strength Cold n hot

Dosage form: patch
Ingredients: MENTHOL 750mg
Labeler: Greenbrier International, Inc.
NDC Code: 33992-8463

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 Facts

Active ingredient                                                           Purpose

Menthol 5%.....................................................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.

Inactive ingredients aloe vera, aluminum hydroxide, disodium EDTA, gelatin, kaolin, methacrylic acid copolymer, methylparaben, polysorbate 80, sorbitan monooleate, 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

ASSURED EXTRA STRENGTH COLD N HOT  
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-8463
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL750 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALUMINUM HYDROXIDE 
EDETATE DISODIUM 
GELATIN 
KAOLIN 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
METHYLPARABEN 
POLYSORBATE 80 
SORBITAN MONOOLEATE 
SORBITOL 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:33992-8463-21 POUCH (POUCH) in 1 CARTON
12 PATCH (PATCH) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/30/2013
Labeler - Greenbrier International, Inc. (610322518)

Revised: 06/2013
 
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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