AREX SINSIN PAS- camphor, mentha oil, menthol, methyl salicylate, zinc oxide patch

Arex Sinsin Pas by

Drug Labeling and Warnings

Arex Sinsin Pas by is a Otc medication manufactured, distributed, or labeled by Sinsin Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.
  

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.

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

Distributed by

SINSIN PHARM AMERICA

Brea, CA 92821

www.sinsinpas.us

Principal Display Panel

INGREDIENTS AND APPEARANCE

AREX SINSIN PAS 
camphor, mentha oil, menthol, methyl salicylate, zinc oxide patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55264-020
Route of Administration	TOPICAL, CUTANEOUS, TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	17.05 mg
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B)	PEPPERMINT OIL	22.73 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	45.45 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	45.45 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	215.91 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)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55264-020-10	1 in 1 CARTON	11/09/2018
1		10 in 1 POUCH; 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	08/31/2015

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(55264-020)