Label: SINSINPAS COLD- l-menthol patch
- NDC Code(s): 55264-104-01, 55264-104-02
- Packager: Sinsin Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 5, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep out of reach of children
- Uses
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Warnings
For external use only
Do not use- on wounds or damaged skin
- if you are allergic to any ingredients of this product
- with a heating pad
- with, or at the same time as, other external analgesic products
When using this product
- do not use otherwise than directed
- avoid contact with eyes, mucous membranes or rashes
- do not bandage tightly
Ask a doctor before use if you are prone to allergic reaction from aspirin or salicylates
Stop use and ask a doctor if
- rash, itching, or excessive skin irritation develops
- conditions worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use.
- Directions
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Inactive Ingredients
Aloe vera gel, BHT, Castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydoxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methyl paraben, PEG monostearte, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate.
- SINSINPAS COLD PATCH
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INGREDIENTS AND APPEARANCE
SINSINPAS COLD
l-menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55264-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.85 g in 17 g Inactive Ingredients Ingredient Name Strength SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) POVIDONE (UNII: FZ989GH94E) METHYLPARABEN (UNII: A2I8C7HI9T) GELATIN (UNII: 2G86QN327L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SILODRATE (UNII: 9T3UU8T0QK) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CASTOR OIL (UNII: D5340Y2I9G) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55264-104-02 4 in 1 POUCH 08/01/2018 1 NDC:55264-104-01 17 g in 1 PATCH; 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 08/01/2018 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(55264-104)