Hydrocortisone
FDA Label NDC 40002-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nexmed (usa), Inc. for the product Hydrocortisone (NDC 40002-003). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, do not use, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch cream

Uses

  • 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, scrapes
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only.

When Using This Product

  • avoid contact with the eyes
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

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, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs

Do Not Use

  • for the treatment of diaper rash. Ask a doctor
  • in the genital area if you have vaginal discharge. Ask a doctor

Keep Out Of Reach Of Children

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

Directions

  • For 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: do not use, consult a doctor
  • Adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • Gently dry by patting or blotting toilet tissue or a soft cloth before application of this product
  • Children under 12 years of age: for external itching consult a doctor

Other Information

Store between 20⁰ and 25⁰C (68⁰ to 77⁰F)

Inactive Ingredients

citric acid, dodecyl-2-N N-dimethylaminopropionate hydrochloride, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, titanium dioxide

Questions?

Call 1-800-866-7391, Mon-Fri, 8:30 AM - 5:30 PM (PST)

Package Label.Principal Display Panel

Image Of Carton And Label (Carton2)

Image Of Carton And Label (Carton2)

* Please review the disclaimer below.