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
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated June 29, 2021
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- Active ingredients
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.
This product contains natural rubber latex which may cause allergic reactions.
- Keep out of reach of children
- Other information
- Inactive ingredients
- Distributed by:
- Principal Display Panel
INGREDIENTS AND APPEARANCE
SINSINPAS AREX INSTANT PAIN RELIEF SMALL
camphor, menthol, mentha oil, methyl salicylate, zinc oxide patch
Product 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 not final part348 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)