CVS THERAPEUTIC MENTHOL PAIN RELIEVER- menthol gel

CVS Therapeutic Menthol Pain Reliever by

Drug Labeling and Warnings

CVS Therapeutic Menthol Pain Reliever by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                 Purpose

Menthol 2%...................................................Topical Analgesic

PURPOSE

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

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

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive Ingredients


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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS THERAPEUTIC MENTHOL PAIN RELIEVER 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-056-36	1 in 1 CARTON
1		227 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/10/2010

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture