hydrocortisone cream usp, 1% with aloe - spl

hydrocortisone cream usp, 1% with aloe - spl
SPL v1
SPL
SPL Set ID 12a1774d-a97e-4787-b6b1-8e8cd40b7b70
Route
topical
Published
Effective Date 2025-09-16
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (1 g)
Inactive Ingredients
aloe vera leaf cetyl alcohol citric acid monohydrate glyceryl monostearate isopropyl myristate methylparaben polyoxyl 40 stearate polysorbate 60 propylene glycol propylparaben water sodium citrate sorbic acid sorbitan monostearate stearyl alcohol white wax

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-02-26

Purpose

Anti-itch

Description

Hydrocortisone USP, 1%


Medication Information

Warnings

For external use only.

Purpose

Anti-itch

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: consult a doctor

■ for external anal and genial itching

■ adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly

■ gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

■ apply to affected area not more than 3 to 4 times daily

■ children under 12 years of age: consult a doctor



Other Information

■ store at 15°C to 30°C (59°F to 86°F). Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.

Description

Hydrocortisone USP, 1%

Principal Display Panel

Hydrocortisone Cream USP, 1% with Aloe

Anti-itch Cream

Net wt. 1 oz (28g)

  

Hydrocortisone Cream USP, 1% with Aloe

Anti-itch Cream

Net wt. 0.5 oz (14g)

Questions?

Call 1-833-285-4151

Use(s)

■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to

    ■ eczema ■ psoriasis ■ insect bites ■ poison ivy, oak sumac

    ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis

■ temporarily relieves external anal and genital itching

■ other uses of this product should be only under the advice and supervision of a doctor

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.

Inactive Ingredient

aloe vera concentrate, cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methyl paraben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, solution*, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax



*Contains one or more of these ingredients to adjust pH

Active Ingredient(s)

Hydrocortisone USP, 1%

When Using This Product

■ avoid contact with the eyes

■ do not use more than directed unless directed by a doctor

■ do not put directly into the rectum by using fingers or any mechanical device or applicator 

Stop Use and Ask Doctor If

■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days

■ do not begin the use of any ether hydrocortisone product unless directed by a doctor

■ rectal bleeding occurs

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center {1-800-222-1222) right away.


Structured Label Content

Warnings (WARNINGS)

For external use only.

Purpose (PURPOSE)

Anti-itch

Directions (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: consult a doctor

■ for external anal and genial itching

■ adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly

■ gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

■ apply to affected area not more than 3 to 4 times daily

■ children under 12 years of age: consult a doctor



Other Information (OTHER INFORMATION)

■ store at 15°C to 30°C (59°F to 86°F). Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Hydrocortisone Cream USP, 1% with Aloe

Anti-itch Cream

Net wt. 1 oz (28g)

  

Hydrocortisone Cream USP, 1% with Aloe

Anti-itch Cream

Net wt. 0.5 oz (14g)

Questions? (QUESTIONS?)

Call 1-833-285-4151

Use(s) (USE(S))

■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to

    ■ eczema ■ psoriasis ■ insect bites ■ poison ivy, oak sumac

    ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis

■ temporarily relieves external anal and genital itching

■ other uses of this product should be only under the advice and supervision of a doctor

Do Not Use (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.

Inactive Ingredient (INACTIVE INGREDIENT)

aloe vera concentrate, cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methyl paraben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, solution*, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax



*Contains one or more of these ingredients to adjust pH

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Hydrocortisone USP, 1%

When Using This Product (WHEN USING THIS PRODUCT)

■ avoid contact with the eyes

■ do not use more than directed unless directed by a doctor

■ do not put directly into the rectum by using fingers or any mechanical device or applicator 

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days

■ do not begin the use of any ether hydrocortisone product unless directed by a doctor

■ rectal bleeding occurs

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control Center {1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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