Hydrocortisone
FDA Label NDC 51141-0065

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neopharm Co., Ltd. for the product Hydrocortisone (NDC 51141-0065). 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, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, 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

temporarily relieves itching associated with minor sin irritation, inflammation and rashes due to:

  • eczema
  • psoriasis
  • seborrheic dermatitis
  • poison ivy, oak, sumac
  • insect bites
  • soaps and detergents
  • cosmetics
  • jewelry
  • external feminine and anal itching
    • Other uses of this product:  ask a doctor

Warnings

For external use only

Do Not Use

  • in or near the eyes
  • by putting directly into the rectum by using fingers or any mechanical device or applicator
  • for external feminine itching if you have a vaginal discharge
  • for diaper rash; ask a doctor

Ask A Doctor Or Pharmacist Before Use If You Are

using any other hydrocortisone product

When Using This Product

for external anal itching, do not exceed recommended daily dosage unless directed by a doctor

Stop Use And Ask A Doctor If

  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • rectal bleeding occurs

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control

Directions

  • apply to affected area not more than 3 to 4 times daily
  • for external anal itching:  when practical, clean area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 2 years, or children under 12 years with external anal itching:  do not use, ask a doctor

Other Information

  • store at room temperature, protect from freezing

Inactive Ingredient

Cetyl alcohol, Butylated hydroxytoluene, Glycerin, Glyceryl monostearate, Isopropyl myristate, Myristoyl/palmitoyl/oxostearamide/arachamide MEA, Methylparaben, PEG-15 glyceryl stearate, Squalane, Stearic acid, Propylparaben, Purified water

Package Label.Principal Display Panel

Hydrocortisone

Image Of Carton Label (Hydro.carton)

Image Of Carton Label (Hydro.carton)

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