Label: SINSINPAS AREXGEL- l-menthol patch
- NDC Code(s): 55264-114-01, 55264-114-02
- Packager: Sinsin Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 5, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- 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
Ask a doctor before use if you are allergic to any ingredients in this product.
When using this product
- do not use other than directed
- avoid contact with eyes, mucous membranes, and rashes
Stop use and ask a doctor if
- rash, itching, or excessive skin irritation develops
- condition worsens
- symptoms persist for longer than 7 days
- symptoms clear up and reoccur within a few days
If pregnant or breast-feeding, ask a health professional before use.
Caution: This product contains natural rubber latex which may cause allergic reactions.
- Keep out of reach of children
- Directions
- Other Information
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Inactive Ingredients
Aloe vera gel, Butylated hydroxytoluene, Carboxymethylcellulose sodium, Castor oil, Concentrated glycerin, Disodium edetate hydrate, Dihydroxyalumium Aminoacetate, Gelatin, Kaolin, Methylparaben, Nonivamide, Polysorbate 80, Purified water, Sodium polyacrylate, Sorbitol, Tartaric acid, Titanium dioxide
- SINSINPAS AREX GEL PATCH
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INGREDIENTS AND APPEARANCE
SINSINPAS AREXGEL
l-menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55264-114 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 96 mg LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 76.8 mg METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 57.6 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) NONIVAMIDE (UNII: S846B891OR) SORBITOL (UNII: 506T60A25R) GELATIN (UNII: 2G86QN327L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) KAOLIN (UNII: 24H4NWX5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CASTOR OIL (UNII: D5340Y2I9G) WATER (UNII: 059QF0KO0R) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55264-114-02 1 in 1 POUCH 08/27/2021 1 NDC:55264-114-01 6 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 08/27/2021 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(55264-114)