CVS EXTRA STRENGTH COLD AND HOT PAIN RELIEVING- menthol cream 
CVS

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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Active ingredients                                                                         Purpose

Menthol 10%..................................................................Topical Analgesic

Methyl Salicylate 30%....................................................Topical Analgesic

Uses temporarily relieves minor pain associated with:

Warnings

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. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients DEA-cetyl phosphate, isopropyl myristate, lanolin, methylparaben, polysorbate 60, propylparaben, stearic acid, stearyl alcohol, trolamine, water

Distributed By:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

Made in Korea

image of carton label

CVS EXTRA STRENGTH COLD AND HOT PAIN RELIEVING 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-469
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-469-091 in 1 CARTON
185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/13/2014
Labeler - CVS (062312574)

Revised: 10/2014
Document Id: 92b7fa57-bd3a-4211-a430-8675447a8ad8
Set id: e8ee945f-edfb-4817-9076-f0d6382d1e4e
Version: 2
Effective Time: 20141013
 
CVS