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Signature Care Cold and Hot Medicated

Dosage form: patch
Ingredients: MENTHOL, UNSPECIFIED FORM 500mg
Labeler: Safeway
NDC Code: 21130-980

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 with a heating pad

Stop use and ask a doctor if
excessive redness or irritation is present
condition worsens
pain persist 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 not more than 4 times daily
children under 12 years: ask 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.

Inactive ingredients

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

Package/Label Principal Display Panel

Principal Display Panel
SIGNATURE CARE COLD AND HOT MEDICATED 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-980
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM500 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
CASTOR OIL 
DIHYDROXYALUMINUM AMINOACETATE 
EDETATE DISODIUM 
GLYCERIN 
HYDROXYPROPYL CELLULOSE (TYPE E) 
KAOLIN 
POLYVINYL ALCOHOL 
POLYACRYLIC ACID (250000 MW) 
WATER 
SORBITOL 
TARTARIC ACID 
Packaging
#Item CodePackage Description
1NDC:21130-980-011 POUCH in 1 CARTON
15 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2015
Labeler - Safeway (009137209)

 
Safeway

Medically reviewed on Dec 3, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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