CVS EXTRA STRENGTH PAIN RELIEF - menthol, methyl salicylate gel 
CVS Pharmacy

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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DRUG FACTS

Active ingredient                                 Purpose

Menthol 7.6%...................................................Topical Analgesic
Methyl Salicylate 29%.......................................Topical Analgesic



Uses
temporary relieves minor pain associated with:

- arthritis - simple backache - muscle strains
- muscle sprains - bruises - cramps


Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center right away.


Uses temporary relieves minor pain associated with:

- arthritis - simple backache - muscle strains
- muscle sprains - bruises - cramps

Warnings

For external use only


Allergy alert: 
if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product
- use only as directed - avoid contact with the eyes or mucous membranes
- do not bandage tightly or use with a heating pad - do not apply to wounds or damaged skin

Ask a doctor before use if - condition worsens - redness is present - irritation develops - symptoms persist
for more than 7 days or 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 of age and older:

- apply generously to affected area
- massage into painful area until thoroughly absorbed into skin
- repeat as necessary, but no more than 4 times dily

children under 12 years of age: consult a doctor

Inactive Ingredients parrafin, petrolatum


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CVS EXTRA STRENGTH PAIN RELIEF 
menthol, methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-620
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL76 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE290 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-620-3599.2 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/10/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2010
Document Id: 8dca210f-2446-4e8c-9071-9e9d909ee089
Set id: a01fc91d-be81-41fc-9ca3-703bff237ef5
Version: 1
Effective Time: 20100710
 
CVS Pharmacy