Ps-2896 Hydrocortisone Cream 1%, 0.9g

Ps-2896 Hydrocortisone Cream 1%, 0.9g
SPL v3
SPL
SPL Set ID 0074e7bf-8c62-a5a7-e063-6394a90a63fc
Route
TOPICAL
Published
Effective Date 2023-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Methylchloroisothiazolinone Stearic Acid Trolamine Propylene Glycol White Petrolatum Cetostearyl Alcohol Glyceryl Monostearate Water

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-31

Description

Hydrocortisone USP 1%

Purpose

Antipruritic (Anti-Itch)


Medication Information

Purpose

Antipruritic (Anti-Itch)

Description

Hydrocortisone USP 1%

Label

PS-2896 Hydrocortisone Cream 1%, 0.9g

Use(s)

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

Warnings

For External Use Only

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: Consult a doctor.

• When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: Consult a doctor before using for anal itching.

Do Not Use

• In the eyes • For diaper rash • For external genital or feminine itching if you have a vaginal discharge • More than the recommended daily dosage unless directed by a doctor • In the rectum by using fingers or any mechanical device or applicator

Questions?

1-888-900-2920 Monday - Friday 8AM - 4PM PST.

Active Ingredient

Hydrocortisone USP 1%

Other Information

• Store at room temperature between 15º-30ºC (59º-86ºF) • Avoid excessive heat • Tamper evident. Do not use if packet is torn, cut, or opened

Inactive Ingredient

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisthiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Petrolatum

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 (do not continue to use this or any other hydrocortisone product for longer than 7 days) • Bleeding occurs due to anal itching

If Pregnant Or Breast Feeding

Ask a health professional before use

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

Label

PS-2896 Hydrocortisone Cream 1%, 0.9g

Use(s)

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

Purpose

Antipruritic (Anti-Itch)

Warnings

For External Use Only

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: Consult a doctor.

• When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: Consult a doctor before using for anal itching.

Do Not Use (Do not use)

• In the eyes • For diaper rash • For external genital or feminine itching if you have a vaginal discharge • More than the recommended daily dosage unless directed by a doctor • In the rectum by using fingers or any mechanical device or applicator

Questions?

1-888-900-2920 Monday - Friday 8AM - 4PM PST.

Active Ingredient

Hydrocortisone USP 1%

Other Information

• Store at room temperature between 15º-30ºC (59º-86ºF) • Avoid excessive heat • Tamper evident. Do not use if packet is torn, cut, or opened

Inactive Ingredient

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisthiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Petrolatum

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 (do not continue to use this or any other hydrocortisone product for longer than 7 days) • Bleeding occurs due to anal itching

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Ask a health professional before use

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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