Preparation H Hydrocortisone Cream
FDA Label NDC 0573-2830

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Preparation H Hydrocortisone (NDC 0573-2830). 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, do not use, when using this product, stop use and ask a doctor if, 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

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • temporary relief of external anal itching
  • temporary relief of itching associated with minor skin irritations and rashes
  • 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. Consult a doctor.

When Using This Product

  • avoid contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

  • bleeding occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Keep Out Of Reach Of Children.

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

Directions

  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product.
  • when first opening the tube, puncture foil seal with top end of cap
  • adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor

Other Information

store at 20-25°C (68-77°F)

Inactive Ingredients

anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, edetate disodium, glycerin, glyceryl oleate, glyceryl stearate, lanolin, methylparaben, propyl gallate, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium benzoate, sodium lauryl sulfate, stearyl alcohol, white petrolatum, xanthan gum

Questions Or Comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374.

Product Packaging

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

PREPARATION H ANTI-ITCH CREAM HYDROCORTISONE 1%

Relieves the Itch

  • Maximum Strength Without a Prescription
  • Effective Relief of Anal Itch
  • Doctor Prescribed Ingredient

    • NET WT 0.9 OZ (26 g)

    Do Not Use if tube seal under cap embossed with “H” is broken or missing.

    For most recent product information, visit www.preparationh.com.

    Wyeth Consumer Healthcare, Madison, NJ 07940 USA

    ©2009 Wyeth

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