Sinsinpas Arex Instant Pain Relief (not For Sale)

Sinsinpas Arex Instant Pain Relief (not For Sale)
SPL v5
SPL
SPL Set ID b37a0686-39f6-36cc-e053-2995a90a831e
Route
TOPICAL
Published
Effective Date 2015-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (17.05 mg) Peppermint (22.73 mg) Levomenthol (45.45 mg) Salicylic Acid (215.91 mg) Zinc Oxide
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 2020-11-06

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

Warnings and Precautions

For external use only

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

Section 43685-7

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.

Section 50565-1

Keep out of reach of children

Section 50566-9

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

Section 50567-7

When using this product

-do not use other than directed

-avoid contact with eyes, mucous membranes, and rashes

Section 50569-3

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

Section 50570-1

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.

Section 53414-9

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

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.
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.

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Structured Label Content

Uses

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Warnings and Precautions (34071-1)

For external use only

Section 43685-7 (43685-7)

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.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

-do not use other than directed

-avoid contact with eyes, mucous membranes, and rashes

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

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

Purpose

Topical Analgesic

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.
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.

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Advanced Ingredient Data


Raw Label Data

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