Proheal hydrocortisone 1% Cream Ultra Soothing Aloe

Proheal hydrocortisone 1% Cream Ultra Soothing Aloe
SPL v1
SPL
SPL Set ID 328c389c-7e05-4892-a9b3-b6a753f4935a
Route
TOPICAL
Published
Effective Date 2025-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Leaf Juice Cetyl Alcohol Glycerin Glyceryl Stearate Se Mineral Oil Peg-100 Monostearate Phenoxyethanol Water Stearyl Alcohol White Petrolatum Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-28

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses:

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, insect bites, poison ivy, oak, or sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, temporarily relieves external anal and external genital itching, other uses of this product should be only under the advice and supervision of a doctor.

Section 42229-5

ULTRA SOOTHING ALOE

Manufactured for: ProHeal

Surfside, FL

www.prohealproducts.com

772-776-4325 (Rev. 08/25)

Section 50565-1

Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.

Packaging

Warnings:

For external use only.

Do not use:  • In the genital area if you have a vaginal discharge. Consult a doctor. • For the treatment of diaper rash. Consult a doctor.

When using this product  • Avoid contact with eyes • Do not use more than directed unless told to do so by a doctor • Do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if  • Rectal bleeding occurs • Condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product unless you have asked a doctor

Directions

For itching of skin irritation, inflammation, and rashes:

• 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, ask a doctor

For external anal and external genital itching, adults:

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly • Gently dry by patting or blotting with toilet tissue or soft cloth before applying • Apply to affected area not more than 3 to 4 times daily • Children under 12 years of age: ask a doctor

Drug Facts

Active Ingredient

Hydrocortisone 1%

Other Information:

Store at 20-25°C (68-77°F)

Inactive Ingredients:

Aloe barbadensis leaf juice, Cetyl alcohol, Glycerin, Glyceryl stearate SE, Mineral oil, PEG-100 stearate, Phenoxyethanol, Purified water, Stearyl alcohol, White petrolatum, Xanthan gum.


Structured Label Content

Uses:

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, insect bites, poison ivy, oak, or sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, temporarily relieves external anal and external genital itching, other uses of this product should be only under the advice and supervision of a doctor.

Section 42229-5 (42229-5)

ULTRA SOOTHING ALOE

Manufactured for: ProHeal

Surfside, FL

www.prohealproducts.com

772-776-4325 (Rev. 08/25)

Section 50565-1 (50565-1)

Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.

Purpose

Anti-Itch

Packaging

Warnings:

For external use only.

Do not use:  • In the genital area if you have a vaginal discharge. Consult a doctor. • For the treatment of diaper rash. Consult a doctor.

When using this product  • Avoid contact with eyes • Do not use more than directed unless told to do so by a doctor • Do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if  • Rectal bleeding occurs • Condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product unless you have asked a doctor

Directions

For itching of skin irritation, inflammation, and rashes:

• 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, ask a doctor

For external anal and external genital itching, adults:

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly • Gently dry by patting or blotting with toilet tissue or soft cloth before applying • Apply to affected area not more than 3 to 4 times daily • Children under 12 years of age: ask a doctor

Drug Facts

Active Ingredient

Hydrocortisone 1%

Other Information: (Other information:)

Store at 20-25°C (68-77°F)

Inactive Ingredients: (Inactive ingredients:)

Aloe barbadensis leaf juice, Cetyl alcohol, Glycerin, Glyceryl stearate SE, Mineral oil, PEG-100 stearate, Phenoxyethanol, Purified water, Stearyl alcohol, White petrolatum, Xanthan gum.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)