CVS EXTRA STRENGTH PAIN RELIEF- menthol, methyl salicylate gel

CVS Extra Strength Pain Relief by

Drug Labeling and Warnings

CVS Extra Strength Pain Relief 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 7.6%...................................................Topical Analgesic
Methyl Salicylate 29%.......................................Topical Analgesic

PURPOSE

Uses temporary relieves minor pain associated with:

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

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 temporary relieves minor pain associated with:

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive Ingredients parrafin, petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS EXTRA STRENGTH PAIN RELIEF 
menthol, methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-620
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	76 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	290 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-620-35	99.2 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not 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