Hydrocortisone Anti-itch Cream
FDA Label NDC 52000-022

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Hydrocortisone Anti-itch (NDC 52000-022). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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

Otc - Active Ingredient

Active Ingredient

Hydrocortisone 1%

Otc - Purpose

Purpose

Anti-itch

Indications & Usage

Uses

for the temporary relief of itching associated with minor skin irritations and rashes due to:

  • eczema
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • external genital, feminine and anal itching

    • Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not usein genital area if you have a vaginal discharge.

Consult a doctor, for the treatment of diaper rash. Ask a doctor.

Otc - When Using

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

Otc - Stop Use

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.

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.

Dosage & Administration

Directions

For itching of skin irritation, inflammation, and rashes:

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: Ask a doctor

For external anal and genital itching, adults:

When practical, clean the affected area with mild soap and 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 3 to 4 times daily. Children under 12 years of age: Ask a doctor.

Other

Other information

  • Store at 20°C to 25° C (68°F to 77° F)
  • Lot No. & Exp. Date: see crimp of tube

Inactive Ingredient

Inactive Ingredients

Purified Water, Mineral Oil, Propylene Glycol, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Polysorbate 60, Sorbitan Stearate, Methylparaben, Propylparaben, Disodium Edta

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

HYDROCORTISONE ANTI-ITCH CREAM

NET WT 0.5 OZ. (14 g)

Label (Hydrocortisone Anti Itch)

Label (Hydrocortisone Anti Itch)

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