SINSINPAS AREX INSTANT PAIN RELIEF (NOT FOR SALE)- camphor, mentha oil, menthol, methyl salicylate, zinc oxide patch

SINSINPAS AREX INSTANT PAIN RELIEF (NOT FOR SALE) by

Drug Labeling and Warnings

SINSINPAS AREX INSTANT PAIN RELIEF (NOT FOR SALE) 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

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 DOCTOR

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

WHEN USING

When using this product

-do not use other than directed

-avoid contact with eyes, mucous membranes, and rashes

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

WARNINGS AND PRECAUTIONS

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.

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

INGREDIENTS AND APPEARANCE

SINSINPAS AREX INSTANT PAIN RELIEF (NOT FOR SALE) 
camphor, mentha oil, menthol, methyl salicylate, zinc oxide patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55264-108
Route of Administration	TOPICAL

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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55264-108-02	1 in 1 CARTON	11/06/2020
1	NDC: 55264-108-01	2 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	11/06/2020

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(55264-108)