MEDICATED PAIN - camphor (synthetic), levomenthol and methyl salicylate patch 
CVS Pharmacy
Reference Label Set Id: 94eee5db-159d-4a91-af64-b0def810d90f

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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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.

CVSpainpadscart.jpg
Carton

CVSpainpadsPDP.jpg
PDP


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     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
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
Inactive Ingredients
Ingredient Name Strength
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)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-606-01 1 in 1 CARTON
1 5 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/02/2001
Labeler - CVS Pharmacy (062312574)
Registrant - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
Name Address ID/FEI Business Operations
Sato Pharmaceutical Co., Ltd. 715699133 manufacture(59779-606)

Revised: 1/2013
Document Id: e41349c2-3144-478e-9cdf-b38ea54c22b6
Set id: 9c3e0c2c-a28d-4c86-86c9-34c6ed62b05c
Version: 1
Effective Time: 20130108
 
CVS Pharmacy