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

arex

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55264-020-10	1 in 1 CARTON	11/09/2018
1		10 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/31/2015

Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)

Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)

Name	Address	ID/FEI	Business Operations
Establishment
Sinsin Pharmaceutical Co., Ltd.		687867143	manufacture(55264-020)

Arex Sinsin Medium