Hydrocortisone Cream
FDA Label NDC 43473-049

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nantong Health & Beyond Hygienic Products Inc. for the product Hydrocortisone (NDC 43473-049). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, 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

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • for the temporary relief of itching associated with minor irritations and rashes
  • other uses of this product should be only under the advice and superivision of a doctor.

Warnings

For external use only.

Do Not Use

for the treatment of diaper rash. Consult a doctor.

Stop Use And Ask A Doctor If

  • condition worsens of lasts more than 7 days, or clears up and occurs again within a few days.
  • you begin use of any other hydrocortisone product
  • bleeding occurs

Keep Out Of Reach Of Children.

If swallowed 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.

Inactive Ingredients

Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Phenoxyethanol, Water

Package Labeling:

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