83781-007

83781-007
SPL v1
SPL
SPL Set ID 0e031aa5-edf4-8c9d-e063-6394a90afee3
Route
TOPICAL
Published
Effective Date 2024-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (1.5 g) Borneol (1.2 g) Menthol (1 g)
Inactive Ingredients
Saffron Artemisia Vulgaris Top Oil Wormwood Eucalyptus Oil Cinnamon Ginger Osmanthus Fragrans Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-02

Description

Borneol 1.2% Camphor 1.5% Menthol 1.0%

Purpose

Topical Anaglesic


Medication Information

Purpose

Topical Anaglesic

Description

Borneol 1.2% Camphor 1.5% Menthol 1.0%

Use

Temporarily relieves muscle soreness and minor joint pains in the knees, back,neck,hips,shoulders,elbows.

Stop Use

·skin reactions such as redness,swelling,blistering or other discomfort occur

·symptoms persist for more than 7 days

Warnings

For external use only.

Questions
Ask Doctor

Children under age of 12

Directions

·Clean and dry the affected area.

·Peel off the large protective film to reveal a small film on the reddish brown patch.

·Partially peel back the protective film and apply the exposed part of the patch to the the site of pain.

·Carefully remove remaining film while pressing the patch firmly on the skin.

·Remove patch from the skin after at most 8-hour application.

Do Not Use

·on wounds or damaged skin

·with a heating pad or device

·with other ointments, creams, sprays, or liniments

·if you are allergic to any ingredients of this product

When Using

·use only as directed

·avoid contact with the eyes, mucous membranes, or rashes

·do not bandage tightly

Active Ingredient

Borneol 1.2%

Camphor 1.5%

Menthol 1.0%

Inactive Ingredients

Dried ginger, Saffron, Wormwood, Mugwort oil, Osmanthus flower oil, Eucalyptus leaf oil,Cinnamon

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Use

Temporarily relieves muscle soreness and minor joint pains in the knees, back,neck,hips,shoulders,elbows.

Purpose

Topical Anaglesic

Stop Use

·skin reactions such as redness,swelling,blistering or other discomfort occur

·symptoms persist for more than 7 days

Warnings

For external use only.

Questions
Ask Doctor

Children under age of 12

Directions

·Clean and dry the affected area.

·Peel off the large protective film to reveal a small film on the reddish brown patch.

·Partially peel back the protective film and apply the exposed part of the patch to the the site of pain.

·Carefully remove remaining film while pressing the patch firmly on the skin.

·Remove patch from the skin after at most 8-hour application.

Do Not Use (Do not use)

·on wounds or damaged skin

·with a heating pad or device

·with other ointments, creams, sprays, or liniments

·if you are allergic to any ingredients of this product

When Using

·use only as directed

·avoid contact with the eyes, mucous membranes, or rashes

·do not bandage tightly

Active Ingredient

Borneol 1.2%

Camphor 1.5%

Menthol 1.0%

Inactive Ingredients (Inactive ingredients)

Dried ginger, Saffron, Wormwood, Mugwort oil, Osmanthus flower oil, Eucalyptus leaf oil,Cinnamon

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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