Dr. Sheffield Hydrocortisone Anti Itch Cream
FDA Label NDC 11527-052

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sheffield Pharmaceuticals Llc for the product Dr. Sheffield Hydrocortisone Anti Itch (NDC 11527-052). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Adults And Children 2 Years And Older

→ Children Under 2 Years Of Age

→ For External Anal Itching:

→ Other Information

→ Inactive Ingredients

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Other

Drug Facts

Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

For 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
external feminine, genital and anal itching.

Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

For external use only

Do Not Use

for the treatment of diaper rash, consult a doctor.
for external genital itching if you have a vaginal discharge, consult a doctor.

When Using This Product

avoid contact with eyes
do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop Use And Ask A Doctor If

If condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

Otc - Keep Out Of Reach Of Children

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

Adults And Children 2 Years And Older

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

Children Under 2 Years Of Age

do not use. Consult a doctor.

For External Anal Itching:

adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
children under 12 years of age with external anal itching: consult a doctor.

Other Information

store at a controlled room temperature 20 - 25°C (68 - 77°F).

Inactive Ingredients

Aloe barbadensis leaf extract, Benzyl alcohol, Ceteareth-20, Cetearyl alcohol, Cetyl palmitate, Glycerin, Isopropyl myristate, Isostearyl neopentanoate, Methylparaben, PEG-40 stearate, Propylene glycol, Purified water