MEDICATED PAIN - camphor (synthetic), levomenthol and methyl salicylate patch
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 ingredients
dl-Camphor 0.5%
l-Menthol 0.4%
Methyl Salicylate 0.8%

Purpose
dl-Camphor   External analgesic
l-Menthol       External analgesic
Methyl Salicylate      External analgesic

Uses temporary relieves minor aches and pains of muscles and joints associated with
■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings
For external use only

Do not use
■ on wounds or on damaged skin

When using this product
■ avoid contact with the eyes
■ do not bandage tightly

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

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

Directions
■ Strip off the polyethylene film and place adhesive pad over affected area.
■ Change pad 1 or 2 times a day
■ Not for children under 4 years.

Inactive ingredients
aluminum hydroxide gel, carbomer, carmellose sodium, edetate disodium, glycerin, malic acid, methacrylic acid and n-butyl acrylate copolymer, partially hydrolyzed polyvinyl alcohol, partially neutralized polyacrylate, PEG 60 hydrogenated castor oil, sorbitol, titanium dioxide, water.

PDP

Carton

MEDICATED PAIN
dl-camphor, l-menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-606
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	4 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (salicylic acid - UNII:O414PZ4LPZ)	METHYL SALICYLATE	8 mg

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYVINYL ALCOHOL (UNII: 532B59J990)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALGELDRATE (UNII: 03J11K103C)
MALIC ACID (UNII: 817L1N4CKP)
WATER (UNII: 059QF0KO0R)
POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)

#	Item Code	Package Description
Packaging
1	NDC:59779-606-01	1 in 1 CARTON
1		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/02/2001	07/23/2013

Labeler - CVS Pharmacy (062312574)

Registrant - Sato Pharmaceutical Co., Ltd. (690575642)

Name	Address	ID/FEI	Business Operations
Establishment
Fuji Seal, Inc.		718023935	label(59779-606) , pack(59779-606)

Name	Address	ID/FEI	Business Operations
Establishment
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(59779-606)

Revised: 1/2016

Document Id: 0bf94ded-ddde-468b-9253-daa1f5d2194e

Set id: 9c3e0c2c-a28d-4c86-86c9-34c6ed62b05c

Version: 2

Effective Time: 20160115

CVS Pharmacy