Label: SINSINPAS AREX FLEX GEL PAIN RELIEVING PATCH- l-menthol patch
- NDC Code(s): 55264-116-01, 55264-116-02
- Packager: Sinsin Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 1, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- INDICATIONS & USAGE
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WARNINGS
For external use only
Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Do not use- on wounds or damaged skin
- if you are allergic to any ingredients of this product
- with a heating pad
When using this product
- use only as directed
- avoid contact with eyes, mucous membranes, and rashes
Stop use and ask a doctor if
- skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
- 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.
- Keep out or reach of children
- Directions
- Other Information
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Inactive Ingredients
Butylated hydroxytoluene, Methylparaben, Polysorbate 80, Castor Oil, D-Sorbitol Solution,
Concentrated Glycerin, Dihydroxyaluminum, Aminoacetate, Disodium Edetate Hydrate, Carboxymethylcellulose sodium, Kaolin, Titanium Dioxide, Sodium Polyacrylate, Aloe Vera Gel, Gelatin, Nikasol TS-620, Tartaric Acid, Nonylic acid vanillyamide, Purified Water - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SINSINPAS AREX FLEX GEL PAIN RELIEVING PATCH
l-menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55264-116 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 57.6 mg CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 96 mg LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 76.8 mg Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) TARTARIC ACID (UNII: W4888I119H) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SORBITOL (UNII: 506T60A25R) GELATIN (UNII: 2G86QN327L) CASTOR OIL (UNII: D5340Y2I9G) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) NONIVAMIDE (UNII: S846B891OR) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) WATER (UNII: 059QF0KO0R) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) KAOLIN (UNII: 24H4NWX5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55264-116-02 1 in 1 POUCH 05/01/2024 1 NDC:55264-116-01 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 05/01/2024 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(55264-116)