Sinsinpas Arex Gel Patch

Sinsinpas Arex Gel Patch
SPL v3
SPL
SPL Set ID ca91bdca-0004-6617-e053-2a95a90ad7a0
Route
TOPICAL
Published
Effective Date 2021-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (96 mg) Levomenthol (76.8 mg) Salicylic Acid (57.6 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium Nonivamide Sorbitol Gelatin Glyceryl Monostearate Edetate Disodium Aluminum Hydroxide Kaolin Aloe Vera Leaf Butylated Hydroxytoluene Castor Oil Water Tartaric Acid Titanium Dioxide Methylparaben Polysorbate 80 Sodium Polyacrylate (8000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-27

Description

L-Menthol 76.8mg Methyl Salicylate 57.6mg DL-Camphor 96.0mg

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

L-Menthol 76.8mg Methyl Salicylate 57.6mg DL-Camphor 96.0mg

Uses

For the temporarily 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 any ingredients of this product
  • 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 in this product.

When using this product

  • do not use other than directed
  • avoid contact with eyes, mucous membranes, and rashes

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

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

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 no more than 3 to 4 times daily for 7 days
  • Remove patch from skin after at most 8 hours’ application

Children undress 12 years of age: consult a doctor

Other Information

  • Avoid storing product in direct sunlight
  • Protect from excessive moisture
Active Ingredients

L-Menthol 76.8mg

Methyl Salicylate 57.6mg

DL-Camphor 96.0mg

Inactive Ingredients

Aloe vera gel, Butylated hydroxytoluene, Carboxymethylcellulose sodium, Castor oil, Concentrated glycerin, Disodium edetate hydrate, Dihydroxyalumium Aminoacetate, Gelatin, Kaolin, Methylparaben, Nonivamide, Polysorbate 80, Purified water, Sodium polyacrylate, Sorbitol, Tartaric acid, Titanium dioxide

Sinsinpas Arex Gel Patch

Keep Out of Reach of Children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Uses

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

  • Arthritis
  • Simple backache
  • Strains
  • Bruises
  • Sprains
Purpose

Topical Analgesic

Warnings

For external use only



Do not use

  • on wounds or damaged skin
  • if you are allergic to any ingredients of this product
  • 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 in this product.

When using this product

  • do not use other than directed
  • avoid contact with eyes, mucous membranes, and rashes

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

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

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 no more than 3 to 4 times daily for 7 days
  • Remove patch from skin after at most 8 hours’ application

Children undress 12 years of age: consult a doctor

Other Information

  • Avoid storing product in direct sunlight
  • Protect from excessive moisture
Active Ingredients

L-Menthol 76.8mg

Methyl Salicylate 57.6mg

DL-Camphor 96.0mg

Inactive Ingredients

Aloe vera gel, Butylated hydroxytoluene, Carboxymethylcellulose sodium, Castor oil, Concentrated glycerin, Disodium edetate hydrate, Dihydroxyalumium Aminoacetate, Gelatin, Kaolin, Methylparaben, Nonivamide, Polysorbate 80, Purified water, Sodium polyacrylate, Sorbitol, Tartaric acid, Titanium dioxide

Sinsinpas Arex Gel Patch (SINSINPAS AREX GEL PATCH)

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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