Zcort Cream
FDA Label NDC 81335-532

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rxdino, Llc for the product Zcort (NDC 81335-532). 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 drug facts active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Front Display Panel And Back Card

Drug Facts Active Ingredients

Hydrocortisone Acetate 1%

Purpose

Anti-Itch

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

Eczema
psoriasis
poison ivy, oak, sumac
insect bites
detergents
jewelry
cosmetics
soaps
seborrheic dermatitis
temporarily relieves external anal and genital itching
other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

for the treatment of diaper rash
if pregnant or nursing - consult a doctor
in the genital area if you have a vaginal discharge - consult a doctor

When Using This Product

avoid contact with eyes
do not use more than directed unless told to do so by a doctor
do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor

if condition worsens or persists for more than 7 days
if condition clears up and occurs again
if rectal bleeding occurs
before using any other hydrocortisone product

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

FOR ITCHING OF SKIN IRRITATION, INFLAMMATION, AND RASHES

adults and children 12 years of age and older apply to affected area not more than 2 to 3 times daily

FOR EXTERNAL ANAL AND GENITAL ITCHING, ADULTS

when practical, clean the affected area with mild soap and warm water and rinse thoroughly
gently dry by patting or blotting with toilet tissue or a soft cloth before applying
apply to affected area not more than 2 to 3 times daily
Ages 12 to 18 years: ask a doctor

Other Information

Contents filled by weight, not volume

Inactive Ingredients

Aloe Barbadenis Leaf Extract, Cetearyl Alcohol, Cocos Nucifera Oil, Dehydroepiandrosterone (DHEA), Emulsifying Wax, Glycerin, Helianthus Annuus Seed Oil, Phenoxyethanol, Simmondsia Chinensis Seed Oil, Stearic Acid, Tocopherol, Water, Xanthan Gum