CVS THERAPEUTIC MENTHOL PAIN RELIEVER - menthol 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 2%...................................................Topical Analgesic



Uses
for the temporary relief of minor aches and pains of muscles and joints
associated with - simple backache - bruises  - sprains  - arthritis  - strains


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



Uses for the temporary relief of minor aches and pains of muscles and joints
associated with - simple backache - bruises  - sprains  - arthritis  - strains

Warnings

For external use only

When using this product

- do not bandage tightly - avoid contact with the eyes
- do not apply to wounds or damaged skin
- do not use with heating pads or other heating devices

Stop use and ask a doctor if - condition worsens or if symptoms persist
for more than 7 days or clear up and occur again within a few days

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 to affected area not more than 3 to 4 times daily

- children under 12 years of age: do not use, consult a doctor

Inactive Ingredients


carbomer 934, FDandC blue no. 1, isopropyl alcohol, menthol, sodium hydroxide, thymol, water


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CVS THERAPEUTIC MENTHOL PAIN RELIEVER 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CARBOMER 934 (UNII: Z135WT9208)  
WATER (UNII: 059QF0KO0R)  
THYMOL (UNII: 3J50XA376E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-056-361 in 1 CARTON
1227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34807/10/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2010
Document Id: 3279cb81-6ab0-4c53-866c-da71484c4eea
Set id: d60c6b4b-e7f8-4a51-b532-79bc51b38697
Version: 1
Effective Time: 20100710
 
CVS Pharmacy