Label: SINSINPAP COOL- levomenthol, thymol, camphor, mentha, eucalyptus patch
- NDC Code(s): 55264-012-04, 55264-012-05
- Packager: Sinsin Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 7, 2025
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- When using this product:
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
- Adults and children 12 years of age and over:apply to affected area not more than 3 to 4 times daily.
- Children under 12 years of age:do not use, consult a doctor
- For easy application: partially peel back protective film and apply exposed patch to the site of pain.
- Carefully remove remaining film while pressing patch to skin for secure adhesion.
- Storage condition
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Inactive ingredients
BHT, Castor oil, Concentrated Glycerin, Disodium edetate hydrate, D-sorbitol, Isopropyl myristate, Kaolin, Magnesium aluminometasilicate, Methyl Paraben, PEG-4 stearate, Polysorbate 80, Titanium dioxide, Carboxymethylcellulose Sodium, Sodium Polyacrylate, Polyvinyl alchol, Gelatin, Tataric acid, Purified water
- Manufactured by:
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SINSINPAP COOL
levomenthol, thymol, camphor, mentha, eucalyptus patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55264-012 Route of Administration TOPICAL, CUTANEOUS, TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 49.4 mg THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 16.5 mg CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 82.4 mg PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL 164.7 mg EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 16.5 mg Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CASTOR OIL (UNII: D5340Y2I9G) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM (UNII: 7FLD91C86K) SORBITOL (UNII: 506T60A25R) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) KAOLIN (UNII: 24H4NWX5CO) SILODRATE (UNII: 9T3UU8T0QK) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-4 STEARATE (UNII: J33E8608YN) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) TARTARIC ACID (UNII: W4888I119H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55264-012-05 1 in 1 CARTON 05/30/2016 1 NDC:55264-012-04 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 05/30/2016 Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161) Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143) Establishment Name Address ID/FEI Business Operations Sinsin Pharmaceutical Co., Ltd. 687867143 manufacture(55264-012)
