CVS MEDICATED PAIN- dl-camphor, l-menthol, 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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Active ingredients

dl-Camphor 0.5%

l-Menthol 0.3%

Methyl salicylate 1.0%

Purpose

dl-Camphor     External analgesic

l-Menthol         External analgesic

Methyl salicylate     External analgesic

Uses  temporarily 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 irritated, broken, or damaged skin    • on wounds    • otherwise than as directed

When using this product

• avoid contact with the eyes or mucous membranes    • do not bandage the area tightly and do not apply local heat (heating pads, lamps, hot water in bags or bottles) because doing so can increase the risk of serious burns

Stop use and ask a doctor if

■ condition worsens    ■ symptoms persist for more than 7 days     ■ symptoms clear up and occur again within a few days

■ excessive irritation of the skin develops

■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

■ when using for pain of arthritis:

     ■ pain persists for more than 10 days     ■ redness is present    ■ in conditions affecting children under 12 years of age

■ you experience pain, swelling, or blistering of the skin (this product should not cause pain or skin damage)

Warning-Rare cases of serious burns have been reported to occur on the skin where OTC external analgesics were applied.  Read and follow all directions and warnings on this label.

Keep out of reach of children to avoid accidental poisoning.

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

Other information

• keep container tightly closed

• store at room temperature (20 - 25 degrees C or 68 - 77 degrees  F)

Inactive ingredients

carbomer 910, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, partially hydrolyzed polyvinyl alcohol, partially neutralized polyacrylate, polysorbate 80, sorbitan monolaurate, sorbitol, tartaric acid, titanium dioxide, water

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CVS MEDICATED PAIN 
dl-camphor, l-menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-518
Route of AdministrationTopical
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL3 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 mg
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CASTOR OIL (UNII: D5340Y2I9G)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
WATER (UNII: 059QF0KO0R)  
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-518-011 in 1 CARTON07/28/201304/01/2017
15 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/28/201304/01/2017
Labeler - CVS Pharmacy (062312574)
Registrant - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Oishi Koseido Co., Ltd.710700410manufacture(59779-518) , pack(59779-518) , label(59779-518)
Establishment
NameAddressID/FEIBusiness Operations
Fuji Seal, Inc.718023935pack(59779-518) , label(59779-518)

Revised: 1/2018
 
CVS Pharmacy