CVS COLD AND HOT MEDICATED XL- 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.

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CVS Cold & Hot Medicated XL Patch, 3ct (NBE Icyhot) SS, 98104, 2020

Active ingredient                                                               Purpose

Menthol 5% .....................................................................Topical analgesic

Uses temporarily relieves minor pain associated with:

Warnings

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.  Do not use on infants.  If swallowed, get medical help or contact a Poison Control Center immediately

Directions

adults and children over 12 years:

children under 12 years:

consult a doctor

Other information

Inactive ingredients

aloe vera gel, BHT, castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydroxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminosilicate, methyl paraben, PEG monostearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

www.cvs.com

Made in South Korea

98104.1

CVS COLD AND HOT MEDICATED XL 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-981
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL750 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GELATIN (UNII: 2G86QN327L)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
SILODRATE ANHYDROUS (UNII: 59110L5W24)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CASTOR OIL (UNII: D5340Y2I9G)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
TARTARIC ACID (UNII: W4888I119H)  
KAOLIN (UNII: 24H4NWX5CO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-981-041 in 1 CARTON11/11/2010
13 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/11/2010
Labeler - CVS PHARMACY, INC. (062312574)

Revised: 10/2020
Document Id: b0b4a435-9b28-64e5-e053-2a95a90a5dfc
Set id: 45ea0981-e7fc-430e-a78b-c647ef1eba72
Version: 7
Effective Time: 20201002
 
CVS PHARMACY, INC.