SINSINPAS AREX INSTANT PAIN RELIEF SMALL- camphor, menthol, mentha oil, methyl salicylate, zinc oxide patch 
Sinsin Pharmaceutical Co., Ltd.

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.

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SINSINPAS AREX INSTANT PAIN RELIEF SMALL

Active ingredients

DL-Camphor 34.10mg

L-Menthol 90.90mg

Mentha Oil 45.46mg

Methyl Salicylate 90.90mg

Zinc Oxide 431.82mg

Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

Warnings

For external use only

Do not use

Ask a doctor before use if you are allergic to any ingredients in this product.

When using this product

Stop use and ask a doctor if

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

Keep out of reach of children

Directions

Adults and children 12 years of age and over:

Children under 12 years of age:

Other information

Inactive ingredients

Benzyl Nicothinamide, Butylated Hydroxytoluene, Calcium Carbonate, Glyceryl Rosinate, Natural Rubber, Polyisobutylene, Polybutene, Quintone, Vanillyl Nonylamide, YS Resin.

FDA NDC No.: 55264-021-06

Distributed by:

SINSIN PHARM AMERICA

Brea, CA 92821

www.sinsinpas.us

Principal Display Panel

SINSINPAS AREX SMALL

SINSINPAS AREX INSTANT PAIN RELIEF SMALL 
camphor, menthol, mentha oil, methyl salicylate, zinc oxide patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-109
Route of AdministrationCUTANEOUS, TOPICAL, TRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)34.1 mg
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL45.46 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL90.9 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE90.9 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE431.82 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55264-109-011 in 1 POUCH06/29/2021
110 in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/29/2021
Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)
Establishment
NameAddressID/FEIBusiness Operations
Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-109)

Revised: 6/2021
Document Id: c5ef6108-c190-2cf2-e053-2995a90a6f13
Set id: c5ef616b-76c9-347f-e053-2a95a90a1dfa
Version: 1
Effective Time: 20210629
 
Sinsin Pharmaceutical Co., Ltd.