76986-004 Active

76986-004 Active
SPL v3
SPL
SPL Set ID 201adf67-773c-34a2-e063-6394a90ac525
Route
TOPICAL
Published
Effective Date 2024-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dexamethasone (0.075 g)
Inactive Ingredients
Echium Plantagineum Seed Oil Tocopherol Polyglyceryl-10 Dioleate Levomenol Borneol Farnesol Ginger Cardiospermum Halicacabum Flowering Top Polyglyceryl-3 Diisostearate Sunflower Oil Unsaponifiables Mineral Oil Zinc Oxide Carnauba Wax Yellow Wax .alpha.-tocopherol Acetate Octyldodecanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-20

Description

Dexamethasone 0.075%

Purpose

Relief of dermatitis itching.


Medication Information

Purpose

Relief of dermatitis itching.

Description

Dexamethasone 0.075%

Use

Used for pruritus, neurodermatitis, contact dermatitis, seborrheic dermatitis, chronic eczema.

Stop Use

Ask a doctor if any burning sensation, redness, or swelling at the site of application or bacterial or fungal infections occurs or if symptoms are not relieved after 1 week of use.

Warnings

For external use only.

Not for infants.

Use with caution in pregnant and lactating women.

Prohibited for those who are allergic to this product.

Allergic persons should be cautious.

Prohibit the use when the properties of the product have changed.

Should not be used on a large scale and for a long time.

Directions

1-2 times a day, take a small amount of application on the affected area and gently rub for a moment.

Do Not Use

If the affected area has been broken, pus or obvious oozing or viral infections (such as herpes, blisters).

When Using

Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.

Active Ingredient

Dexamethasone 0.075%

Other Information

If you are using other drugs, please consult your physician or pharmacist before using this product.

Athletes should use it with caution.

Sealed, stored in a cool place.

Inactive Ingredients

Mineral Oil, Zinc Oxide, Beeswax, Copernicia Cerifera (Carnauba) Wax, Polyglyceryl-3 Diisostearate, Tocopheryl Acetate, Bisabolol, Octyldodecanol, Polyglyceryl-10 Dioleate, Borneol, Echium Plantagineum Seed Oil, Farnesol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Zingiber Officinale (Ginger) Root Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Tocopherol.

Principal Display Panel

Keep Oot of Reach of Children

Children must be used under adult supervision. In case of accidental ingestion, get medical help or contact a poison control center immediately.


Structured Label Content

Use

Used for pruritus, neurodermatitis, contact dermatitis, seborrheic dermatitis, chronic eczema.

Purpose

Relief of dermatitis itching.

Stop Use

Ask a doctor if any burning sensation, redness, or swelling at the site of application or bacterial or fungal infections occurs or if symptoms are not relieved after 1 week of use.

Warnings

For external use only.

Not for infants.

Use with caution in pregnant and lactating women.

Prohibited for those who are allergic to this product.

Allergic persons should be cautious.

Prohibit the use when the properties of the product have changed.

Should not be used on a large scale and for a long time.

Directions

1-2 times a day, take a small amount of application on the affected area and gently rub for a moment.

Do Not Use (Do not use)

If the affected area has been broken, pus or obvious oozing or viral infections (such as herpes, blisters).

When Using

Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.

Active Ingredient

Dexamethasone 0.075%

Other Information (Other information)

If you are using other drugs, please consult your physician or pharmacist before using this product.

Athletes should use it with caution.

Sealed, stored in a cool place.

Inactive Ingredients (Inactive ingredients)

Mineral Oil, Zinc Oxide, Beeswax, Copernicia Cerifera (Carnauba) Wax, Polyglyceryl-3 Diisostearate, Tocopheryl Acetate, Bisabolol, Octyldodecanol, Polyglyceryl-10 Dioleate, Borneol, Echium Plantagineum Seed Oil, Farnesol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Zingiber Officinale (Ginger) Root Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Tocopherol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Children must be used under adult supervision. In case of accidental ingestion, get medical help or contact a poison control center immediately.


Advanced Ingredient Data


Raw Label Data

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