Label: MEDICATED PAIN - camphor (synthetic), levomenthol and methyl salicylate patch
- NDC Code(s): 59779-606-01
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 INGREDIENT
Methyl Salicylate 0.8%
dl-Camphor External analgesic
l-Menthol External analgesic
Methyl Salicylate External analgesic
- INDICATIONS & USAGE
Uses temporary relieves minor aches and pains of muscles and joints associated withClose
■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains
For external use only
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.
- DOSAGE & ADMINISTRATION
■ 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 INGREDIENT
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.
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
dl-camphor, l-menthol, methyl salicylate patch
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-606 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 5 mg LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL 4 mg METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 8 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM POLYVINYL ALCOHOL SORBITOL GLYCERIN TITANIUM DIOXIDE EDETATE DISODIUM ALGELDRATE MALIC ACID WATER POLYOXYL 60 HYDROGENATED CASTOR OIL 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)