2045 Hydrocortisone Cream Usp 1%

2045 Hydrocortisone Cream Usp 1%
SPL v3
SPL
SPL Set ID f707bda4-074a-6406-e053-6394a90a7ae1
Route
TOPICAL
Published
Effective Date 2023-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-10

Description

Hydrocortisone USP 1%

Purpose

Antipruritic (Anti-Itch)


Medication Information

Purpose

Antipruritic (Anti-Itch)

Description

Hydrocortisone USP 1%

Label

Hydrocortisone Cream USP 1%

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 for external genital, feminine, and anal itching

Warnings

For Exteranl 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 15º-30ºC (59º-86ºF) • Avoid excessive heat • Tamper Evident. Do not use if packet is torn, cut, or opened.

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, 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

Hydrocortisone Cream USP 1%

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 for external genital, feminine, and anal itching

Purpose

Antipruritic (Anti-Itch)

Warnings

For Exteranl 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 15º-30ºC (59º-86ºF) • Avoid excessive heat • Tamper Evident. Do not use if packet is torn, cut, or opened.

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, 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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