Hydrocortisone Cream
FDA Label NDC 63187-575

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Hydrocortisone (NDC 63187-575). 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, ask a doctor before use if you have, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Active Ingredient

Hydrocortisone 0.5%

Purpose

Anti-itch cream

Uses

  • temporary relief of itching associated with minor skin irritations and rashes due to
    • eczema
    • insect bites
    • poison ivy, poison oak, or poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • external 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

  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask A Doctor Before Use If You Have

  • a vaginal discharge
  • rectal bleeding
  • diaper rash

Otc - When Using

When using this product consult a doctor before exceeding recommended dosage

Stop Use And Ask A Doctor If

  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted 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.

Directions

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

For External Anal Itching:

  • Adults: when practical, cleanse 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 application of this product

    • Children under 12 years of age: consult a doctor

Other Information

  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

aloe barbadensis, cetostearyl alcohol, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, stearyl alcohol

Questions?

Call 1-866-923-4914

Principal Display Panel - 28.4 G Tube Carton

Itch and Rash Relief

Sensitive Skin

Hydrocortisone ½%
Cream
Antipruritic (Anti-Itch)

With Aloe

NET WT 1 oz (28.4 g)

63187-575-01 (Hydrocortisone 01)

63187-575-01 (Hydrocortisone 01)

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