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Equate Cool and Heat Extra Strength

Dosage form: patch
Ingredients: MENTHOL 50mg
Labeler: Wal-Mart Stores Inc
NDC Code: 49035-888

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

Menthol 5%

Purpose

Menthol - Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to

arthritis
simple backache
strains
sprains
bursitis
tendonitis
bruises
cramps

Warnings

For external use only

When using this product
use only as directed
avoid contact with eyes or on mucous membranes
do not apply to wounds or to damaged or very sensitive skin
do not bandage tightly or use a heating pad

Stop use and ask a doctor if
excessive redness or irritation is present
condition worsens
pain persists for more than 7 days
symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

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 and over: apply patch to affected area as needed but no more than 4 times daily
children under 12 years: ask a doctor
for easy application: grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates. Remove protective film while applying pad directly to site of pain.

Inactive ingredients

carbomer homopolymer, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxypropyl cellulose, kaolin, partially neutralized polycrylate, polyvinyl alcohol, purified water, sorbitol solution, tartaric acid

Questions?

Call: 1-888-287-1915

Package/Label Principal Display Panel

Package/Label Principal Display Panel
EQUATE COOL AND HEAT  EXTRA STRENGTH
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-888
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL50 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CARBOXYMETHYLCELLULOSE SODIUM 
CASTOR OIL 
DIHYDROXYALUMINUM AMINOACETATE 
EDETATE DISODIUM 
GLYCERIN 
ISOPROPYL MYRISTATE 
POLYVINYL ALCOHOL 
POLYACRYLIC ACID (250000 MW) 
WATER 
SORBITOL 
TARTARIC ACID 
HYDROXYPROPYL CELLULOSE (TYPE E) 
Packaging
#Item CodePackage Description
1NDC:49035-888-301 POUCH in 1 CARTON
15 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2014
Labeler - Wal-Mart Stores Inc (051957769)

Revised: 12/2010
 
Wal-Mart Stores 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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