570-3124 Hydrocortisone Cream 1% Ndc 0404-0166-50

570-3124 Hydrocortisone Cream 1% Ndc 0404-0166-50
SPL v4
SPL
SPL Set ID eb031535-d17e-9d5e-e053-2a95a90ad3e0
Route
TOPICAL
Published
Effective Date 2022-11-07
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 White Petrolatum Stearic Acid

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-07

Description

Hydrocortisone USP 1%

Purpose

Antipruritic (Anti-Itch)


Medication Information

Purpose

Antipruritic (Anti-Itch)

Description

Hydrocortisone USP 1%

Label

Hydrocortisone Cream 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 External Use Only

If pregnant or breastfeeding, ask a health professional before use

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 using for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with bathroom tissue or soft cloth befor 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-DYNAREX Monday-Friday, 9AM-5PM EST

Active Ingredient

Hydrocortisone USP 1%

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat

• Tamper Evident. Do not use if seal is damaged.

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, 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 that 7 days

• In case of bleeding when used for anal itching

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 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 External Use Only

If pregnant or breastfeeding, ask a health professional before use

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 using for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with bathroom tissue or soft cloth befor 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-DYNAREX Monday-Friday, 9AM-5PM EST

Active Ingredient

Hydrocortisone USP 1%

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat

• Tamper Evident. Do not use if seal is damaged.

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, 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 that 7 days

• In case of bleeding when used for anal itching

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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