SINSINPAS AREX PAIN RELIEVING PATCH, MEDIUM- camphor, menthol, methyl salicylate patch

Sinsinpas Arex Pain Relieving Patch, Medium by

Drug Labeling and Warnings

Sinsinpas Arex Pain Relieving Patch, Medium by is a Otc medication manufactured, distributed, or labeled by Sinsin Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DL-Camphor 17.05 mg
L-Menthol 45.45 mg
Methyl Salicylate 45.45 mg

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

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.

PREGNANCY OR BREAST FEEDING

If pregnant and/or breast feeding, ask a health professional before use

STOP USE

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

WHEN USING

When using this product

Do not use other than directed
Avoid contact with eyes, mucous membranes, and rashes

WARNINGS AND PRECAUTIONS

This product contains natural rubber which may cause allergic reactions.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

Mentha Oil, Zinc Oxide, Benzyl Nicothinamide, Butylated Hydroxytoluene, Calcium Carbonate, Glyceryl Rosinate, Natural Rubber, Polyisobutylene, Polybutene, Quintone, Vanillyl Nonylamide, YSResin.

Manufactured by:

SINSIN PHARM. CO., LTD.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SINSINPAS AREX PAIN RELIEVING PATCH, MEDIUM 
camphor, menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55264-022
Route of Administration	TRANSDERMAL, TOPICAL, CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	45.45 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	45.45 mg
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	17.05 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYISOBUTYLENE (200000 MW) (UNII: Z6Y02I0591)
ROSIN (UNII: 88S87KL877)
CALCIUM CARBONATE (UNII: H0G9379FGK)
PEPPERMINT OIL (UNII: AV092KU4JH)
NONIVAMIDE (UNII: S846B891OR)
ZINC OXIDE (UNII: SOI2LOH54Z)
BENZYL NICOTINAMIDE (UNII: HF1W0213QP)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55264-022-11	1 in 1 CARTON	02/01/2025
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 Drug	M017	02/01/2025

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

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