76986-006

76986-006
SPL v1
SPL
SPL Set ID 3616980a-03dc-deba-e063-6394a90a6ce7
Route
TOPICAL
Published
Effective Date 2025-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.1 g)
Inactive Ingredients
.alpha.-tocopherol Acetate Octyldodecanol Tocopherol Zinc Oxide Helianthus Annuus (sunflower) Seed Oil Unsaponifiables Polyglyceryl-3 Diisostearate Polyglyceryl-10 Dioleate Echium Plantagineum Seed Oil Beeswax Farnesol Ginger Cardiospermum Halicacabum Flowering Top Mineral Oil Copernicia Cerifera (carnauba) Wax Bisabolol Borneol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-27

Description

HYDROCORTISONE 0.1%

Purpose

Relief of dermatitis itching.


Medication Information

Purpose

Relief of dermatitis itching.

Description

HYDROCORTISONE 0.1%

Use

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

Stop Use

Stop using and ask a doctor if any burning sensation, redness, or swelling at the site of application 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 of this product when the properties of the product have changed.

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

Ask Doctor

In case of accidental ingestion, get medical help or contact a poison control center immediately.

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

When using this product, avoid contact with eyes, nose and mouth. If contact occurs, rinse thoroughly with water.

Active Ingredient

HYDROCORTISONE 0.1%

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

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 Out of Reach of Children

Keep out of reach of children. Children must be used under adults supervision.


Structured Label Content

Use

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

Purpose

Relief of dermatitis itching.

Stop Use

Stop using and ask a doctor if any burning sensation, redness, or swelling at the site of application 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 of this product when the properties of the product have changed.

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

Ask Doctor

In case of accidental ingestion, get medical help or contact a poison control center immediately.

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)

Do not use if the affected area has been broken, pus or obvious oozing or viral infections (such as herpes, blisters).

When Using

When using this product, avoid contact with eyes, nose and mouth. If contact occurs, rinse thoroughly with water.

Active Ingredient

HYDROCORTISONE 0.1%

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

Keep out of reach of children. Children must be used under adults supervision.


Advanced Ingredient Data


Raw Label Data

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