CVS COLD HOT MEDICATED- menthol patch 
CVS Pharmacy Inc.

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:

For external use only

When using this product

Stop use and ask a doctor if

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 Poision Control Center right away.

Directions: adults and children 12 years of age and older

Other Information

Inactive Ingredients:

1,3 butylene glycol, aloe vera (powder), dibutylhydroxytoluene, disodium edetate, d-sorbital solution, glycerine, kaolin, light liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium methaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate

DISTRIBUTED BY:

CVS PHARMACY, INC.

ONE CVS DRIVE

WOONSOCKET, RI 02895 USA

image description

CVS COLD HOT MEDICATED 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-821
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALOE VERA FLOWER (UNII: 575DY8C1ER)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-821-055 in 1 BOX
1.05 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/14/2013
Labeler - CVS Pharmacy Inc. (062312574)

Revised: 10/2013
Document Id: 654e7ef3-27f3-42d5-831e-e88d32996368
Set id: 5bb28ba7-ba45-4826-92e3-60ea46096ae5
Version: 2
Effective Time: 20131014
 
CVS Pharmacy Inc.