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 Type HUMAN OTC DRUG Item Code (Source) NDC:59779-469
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 30 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-469-09 1 in 1 CARTON
1 85 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 10/13/2014
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