Label: SINSINPAS AREX INSTANT PAIN RELIEF SMALL- camphor, menthol, mentha oil, methyl salicylate, zinc oxide patch
- NDC Code(s): 55264-109-01
- Packager: Sinsin Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 5, 2024
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- 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 aspirin or salicylates
- 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
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
Caution
This product contains natural rubber latex which may cause allergic reactions.
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
SINSINPAS AREX INSTANT PAIN RELIEF SMALL
camphor, menthol, mentha oil, methyl salicylate, zinc oxide patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55264-109 Route of Administration CUTANEOUS, TOPICAL, TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 34.1 mg PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL 45.46 mg LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 90.9 mg METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 90.9 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 431.82 mg Inactive Ingredients Ingredient Name Strength BENZYL NICOTINAMIDE (UNII: HF1W0213QP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CALCIUM CARBONATE (UNII: H0G9379FGK) GLYCERIN (UNII: PDC6A3C0OX) ROSIN (UNII: 88S87KL877) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) POLYISOBUTYLENE (200000 MW) (UNII: Z6Y02I0591) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) NONIVAMIDE (UNII: S846B891OR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55264-109-01 1 in 1 POUCH 06/29/2021 1 10 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 06/29/2021 Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161) Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161) Establishment Name Address ID/FEI Business Operations Sinsin Pharmaceutical Co., Ltd. 687867143 manufacture(55264-109)
