Label: SATOGESIC- dl-camphor, l-menthol, methyl salicylate patch
- NDC Code(s): 49873-060-01, 49873-060-02
- Packager: Sato Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 9, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
For external use onlyWhen using this product
■ avoid contact with the eyes or mucous membranes ■ do not bandage the areatightly 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 upand 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)
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive ingredients
carbomer 940, carboxymethylcellulose sodium, dried aluminum hydroxide gel, edetatedisodium, 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
-
INGREDIENTS AND APPEARANCE
SATOGESIC
dl-camphor, l-menthol, methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-060 Route of Administration TOPICAL 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) MALIC ACID (UNII: 817L1N4CKP) WATER (UNII: 059QF0KO0R) POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) ALGELDRATE (UNII: 03J11K103C) BUTYL ACRYLATE/METHACRYLIC ACID COPOLYMER (2% METHACRYLIC ACID) (UNII: Q984S31CYH) CARBOMER 940 (UNII: 4Q93RCW27E) ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49873-060-01 1 in 1 CARTON 12/03/1990 1 5 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:49873-060-02 1 in 1 CARTON 12/03/1990 2 5 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 12/03/1990 Labeler - Sato Pharmaceutical Co., Ltd. (690575642) Establishment Name Address ID/FEI Business Operations Sato Pharmaceutical Co., Ltd. 715699133 manufacture(49873-060) , label(49873-060) , pack(49873-060) Establishment Name Address ID/FEI Business Operations Fuji Seal, Inc. 718023935 pack(49873-060) , label(49873-060)