Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5de707b4-cb2d-4156-b9dc-a52543d6b23b
Route
TOPICAL
Published
Effective Date 2012-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (21.21 mg) Menthol (14.14 mg) Salicylic Acid (64.45 mg)
Inactive Ingredients
Mustard Seed Achyranthes Bidentata Root Drynaria Fortunei Root Fallopia Multiflora Root Chaenomeles Sinensis Fruit Dipsacus Asper Root Eupatorium Japonicum Whole Zedoary Eleutherococcus Nodiflorus Root Bark Piper Kadsura Stem Justicia Gendarussa Leaf Paris Polyphylla Root Platycodon Grandiflorum Root Rhubarb Angelica Pubescens Root Eucommia Ulmoides Bark Safflower Rehmannia Glutinosa Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1981-11-02

Description

Camphor- 21.21 mg Menthol- 14.14 mg Methyl Salicylate- 65.45 mg


Medication Information

Description

Camphor- 21.21 mg Menthol- 14.14 mg Methyl Salicylate- 65.45 mg

Uses

For the temporary relief of minor aches and pains of muscles or joints due to:

  • Simple backache
  • Arthritis
  • Sprains
  • Bruises
  • Strains
Storage

Store at 15°C to 30°C (59°F to 86°F)

Keep Away From Heat

Warnings

For external use only

Packaging

Directions

Adults and children 12 years of age and older- apply one or two plasters to affected area once a day, remove after 12 hours

Children 2 to 12 years and adults with compromised health- use only under the guidance of a doctor

Children under 2 years of age- do not use

Do Not Use

On wounds

On irritated or damaged skin

If the color of the product has changed

In excess of 12 hours

If known sensitive to the product

Active Ingredients

Camphor- 21.21 mg

Menthol- 14.14 mg

Methyl Salicylate- 65.45 mg

Inactive Ingredients

Mustard Seed, Twotoothed Achranthes Root, Fortune's Drynaria Rhizome, Fleeceflower Root, Common Floweringqince Fruit, Himalayan Teasel Root, Hirsute Shiny Bugleweed Herb, Zedoary Rhizome, Slenderstyle Acanthopanax Bark, Thickleaf Croton Root, Root of Fruitcose Brevnia, Paris Root, Platycodon, Rhubarb, Doubleteeth Pubesscent Angelica Root, Eucommia Bark, Safflower, Rehmannia Root

When Using This Product

Avoid contact with eyes and mucous membranes

Do not bandage tightly

Supervise child use

Use caution if prone to allergic reactions

Stop Use and Ask Doctor If

Condition worsens

Symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Excessive irritation of the skin develops

When Using for Pain of Arthritis: Stop Use If

Pain persists for more than 10 days

Redness is present

In conditions affecting children under 12 years of age

Ask A Doctor Or A Pharmacist Before Use If You Are

Pregnant

Taking other medications


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles or joints due to:

  • Simple backache
  • Arthritis
  • Sprains
  • Bruises
  • Strains
Storage

Store at 15°C to 30°C (59°F to 86°F)

Keep Away From Heat

Warnings

For external use only

Packaging

Directions

Adults and children 12 years of age and older- apply one or two plasters to affected area once a day, remove after 12 hours

Children 2 to 12 years and adults with compromised health- use only under the guidance of a doctor

Children under 2 years of age- do not use

Do Not Use

On wounds

On irritated or damaged skin

If the color of the product has changed

In excess of 12 hours

If known sensitive to the product

Active Ingredients

Camphor- 21.21 mg

Menthol- 14.14 mg

Methyl Salicylate- 65.45 mg

Inactive Ingredients

Mustard Seed, Twotoothed Achranthes Root, Fortune's Drynaria Rhizome, Fleeceflower Root, Common Floweringqince Fruit, Himalayan Teasel Root, Hirsute Shiny Bugleweed Herb, Zedoary Rhizome, Slenderstyle Acanthopanax Bark, Thickleaf Croton Root, Root of Fruitcose Brevnia, Paris Root, Platycodon, Rhubarb, Doubleteeth Pubesscent Angelica Root, Eucommia Bark, Safflower, Rehmannia Root

When Using This Product

Avoid contact with eyes and mucous membranes

Do not bandage tightly

Supervise child use

Use caution if prone to allergic reactions

Stop Use and Ask Doctor If (Stop use and ask doctor if)

Condition worsens

Symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Excessive irritation of the skin develops

When Using for Pain of Arthritis: Stop Use If

Pain persists for more than 10 days

Redness is present

In conditions affecting children under 12 years of age

Ask A Doctor Or A Pharmacist Before Use If You Are (Ask a doctor or a pharmacist before use if you are)

Pregnant

Taking other medications


Advanced Ingredient Data


Raw Label Data

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