Hydrocortisone Acetate Cream
FDA Label NDC 47832-205

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bentlin Products Llc for the product Hydrocortisone Acetate (NDC 47832-205). 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

Drug Facts

Active Ingredient

Hydrocortisone acetate USP 1.0% w/w

Purpose

Anti-itch

Uses:

For temporary relief of itching associated with minor skin irritation, inflammation and rashes due to:

  • Atopic eczema
  • Contact dermatitis from soaps, detergents or cosmetics
  • Seborrheic dermatitis
  • Psoriasis

    • 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
  • On children under the age of 2 except under the supervision of a doctor

When Using This Product

  • Avoid contact with the eyes
  • Do not begin use any other hydrocortisone product unless directed by a doctor

Stop Use And Ask A Doctor If

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days

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

Children Under 2 Years Of Age

Do not use. Consult a doctor.

Other Information

Store between 20°-25°C (68°-77°F)

Inactive Ingredients

caprylic/capric triglyceride, caprytyl glycol, ceteareth-20, chamomillia recutitia flower extract, citric acid, glycerin, glyceryl, stearate, palmitic acid. petrolatum phenoxyethanol, stearic acid, purified water

Questions Or Comments?

Call 908 630 9445 weekdays 9:00am to 4:30pm EST or visit us online at www.exederm.com

Principal Display Panel - 2 Oz Carton Label

NDC 47832-205-34

exederm®

flare control cream
for eczema & dermatitis

NET WT 2 OZ (56g)

1% Hydrocortisone Anti-Itch Cream

Principal Display Panel (2 oz Carton Label)

Principal Display Panel (2 oz Carton Label)

* Please review the disclaimer below.