absolut skin corticosoothe anti-itch cream

absolut skin corticosoothe anti-itch cream
SPL v1
SPL
SPL Set ID deb52218-9176-4aaa-a22f-b66dada6690f
Route
topical
Published
Effective Date 2025-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (10 mg)
Inactive Ingredients
aloe vera leaf juice chamaemelum nobile flower oil behentrimonium methosulfate shea butter cetostearyl alcohol cetyl alcohol coconut oil edetate disodium glycerin phenoxyethanol polysorbate 60 sodium hydroxide stearic acid cocoa butter tocopherol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-09-12

Purpose

Anti-itch

Description

Hydrocortisone USP I .00%


Medication Information

Warnings

For external use only

Purpose

Anti-itch

Directions

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: Do not use, consult a doctor. • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. or by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.• Children under 12 years of age: consult a doctor.

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

Aloe Barbadensis Leaf Juice, Anthemis Nobilis Flower Oil, Behentrimonium Methosulfate, Butyrospermum Parkii(Shea)Butter,Cetearyl Alcohol, Cetyl Alcohol, Cocos Nucifera(Coconut) Oil, Disodium EDTA, Glycerin, Phenoxyethanol, Polysorbate 60, Sodium Hydroxide, Stearic Acid, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water (Aqua)

Description

Hydrocortisone USP I .00%

Uses:

• For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, or poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital feminine and anal itching.

• Other uses of this product should be only under the advice and supervision of a doctor.

Do Not Use

• for the treatment of diaper rash. Consult a doctor.

• if you have a vaginal discharge. Consult a doctor.

Drug Facts

Package Labeling:

Active Ingredients

Hydrocortisone USP I .00%

When Using This Product

• Avoid contact with the eyes. • Do not exceed the recommended daily dosage unless directed by a doctor.• In case of bleeding, consult a doctor promptly.  • Do not put this product into the rectum by using fingers or any mechanical device or applicator. 

Stop Use and Ask A Doctor If

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only

Purpose

Anti-itch

Directions

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: Do not use, consult a doctor. • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. or by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.• Children under 12 years of age: consult a doctor.

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

Aloe Barbadensis Leaf Juice, Anthemis Nobilis Flower Oil, Behentrimonium Methosulfate, Butyrospermum Parkii(Shea)Butter,Cetearyl Alcohol, Cetyl Alcohol, Cocos Nucifera(Coconut) Oil, Disodium EDTA, Glycerin, Phenoxyethanol, Polysorbate 60, Sodium Hydroxide, Stearic Acid, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water (Aqua)

Uses:

• For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, or poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital feminine and anal itching.

• Other uses of this product should be only under the advice and supervision of a doctor.

Do Not Use (Do not use)

• for the treatment of diaper rash. Consult a doctor.

• if you have a vaginal discharge. Consult a doctor.

Drug Facts

Package Labeling:

Active Ingredients

Hydrocortisone USP I .00%

When Using This Product (When using this product)

• Avoid contact with the eyes. • Do not exceed the recommended daily dosage unless directed by a doctor.• In case of bleeding, consult a doctor promptly.  • Do not put this product into the rectum by using fingers or any mechanical device or applicator. 

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

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

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

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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