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Arex Sinsin Pas by Sinsin Pharmaceutical Co., Ltd.

Medically reviewed on August 31, 2018

Dosage form: patch
Ingredients: CAMPHOR (SYNTHETIC) 17.05mg, PEPPERMINT OIL 22.73mg, LEVOMENTHOL 45.45mg, METHYL SALICYLATE 45.45mg, ZINC OXIDE 215.91mg
Labeler: Sinsin Pharmaceutical Co., Ltd.
NDC Code: 55264-020

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.

Drug Facts

Active ingredients

DL-Camphor 17.05mg

L-Menthol 45.45mg

Mentha Oil 22.73mg

Methyl Salicylate 45.45mg

Zinc Oxide 215.91mg

Purpose

Topical Analgesic

Uses

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

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 of this product

When using this product
  • do not use otherwise than directed.
  • avoid contact with the eyes, mucous membranes or rashes.

Stop use and ask a doctor if
  • rash, itching or excessive skin irritation develops.
  • conditions worsen.
  • symptoms persist for more than 7 days.
  • symptoms clear up and occur again within a few days.

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.

Directions Adults and children 12 years of age and over:
  • Clean and dry affected area
  • Remove patch from film.
  • Apply to affected area not more than 3 to 4 times daily for 7 days.
  • Remove patch from skin after at most 8 hours application.
Children under 12 years of age:
  • Consult a doctor.

Other information
  • avoid storing product in direct sunlight
  • protect from excessive moisture

Inactive ingredients

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

FDA NDC No.: 55264-020-10

Manufactured by:

SINSIN PHARM. CO., LTD.

90, Beomjigi-ro 141 beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea

tel: 82-31-776-1140~3 http://www.sinsin.com

Principal Display Panel
AREX SINSIN PAS 
camphor, mentha oil, menthol, methyl salicylate, zinc oxide patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-020
Route of AdministrationTOPICAL, CUTANEOUS, TRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)17.05 mg
PEPPERMINT OIL (PEPPERMINT) PEPPERMINT OIL22.73 mg
LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL45.45 mg
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE45.45 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE215.91 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL NICOTINAMIDE 
BUTYLATED HYDROXYTOLUENE 
CALCIUM CARBONATE 
GLYCERIN 
ROSIN 
NATURAL LATEX RUBBER 
POLYISOBUTYLENE (200000 MW) 
POLYBUTENE (1400 MW) 
NONIVAMIDE 
Packaging
#Item CodePackage Description
1NDC:55264-020-101 POUCH in 1 CARTON
110 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/31/2015
Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)
Establishment
NameAddressID/FEIOperations
Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-020)

 
Sinsin Pharmaceutical Co., Ltd.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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