Arex Sinsin Medium

Arex Sinsin Medium
SPL v10
SPL
SPL Set ID 2013ea44-e2ea-4b36-bddb-7f64163284b6
Routes
CUTANEOUS TRANSDERMAL TOPICAL
Published
Effective Date 2015-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (45.45 mg) Salicylic Acid (215.91 mg) Zinc Oxide (17.05 mg) Camphor (synthetic) (22.73 mg) Peppermint
Inactive Ingredients
Benzyl Nicotinamide Butylated Hydroxytoluene Calcium Carbonate Glycerin Rosin Natural Latex Rubber Polyisobutylene (200000 Mw) Polybutene (1400 Mw) Nonivamide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-08-31

Description

DL-Camphor 17.05mg L-Menthol 45.45mg Mentha Oil 22.73mg Methyl Salicylate 45.45mg Zinc Oxide 215.91mg

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

DL-Camphor 17.05mg L-Menthol 45.45mg Mentha Oil 22.73mg Methyl Salicylate 45.45mg Zinc Oxide 215.91mg

Uses

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

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.
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.
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

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

Active Ingredients

DL-Camphor 17.05mg

L-Menthol 45.45mg

Mentha Oil 22.73mg

Methyl Salicylate 45.45mg

Zinc Oxide 215.91mg

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

Ask A Doctor Before Use

if you are allergic to any ingredients of this product

Principal Display Panel

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.


Structured Label Content

Uses

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Purpose

Topical Analgesic

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.
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.
Manufactured By: (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

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

Active Ingredients (Active ingredients)

DL-Camphor 17.05mg

L-Menthol 45.45mg

Mentha Oil 22.73mg

Methyl Salicylate 45.45mg

Zinc Oxide 215.91mg

Inactive Ingredients (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

Ask A Doctor Before Use (Ask a doctor before use)

if you are allergic to any ingredients of this product

Principal Display Panel

When Using 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 (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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