Hydrocortisone
FDA Label NDC 51141-0002

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 51141-0002). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active IngredientHydrocortisone 1%

Otc - Purpose

Purpose
Anti-itch

Otc - Keep Out Of Reach Of Children

Keep out of reach of children
if swallowed, get medical help or contact a Poison Control

Indications & Usage

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

  •   psoriasis
  •   seborrheic dermatitis
  •   poison ivy,oak,sumac
  •   insect bites


    • Other uses of this product: ask a doctor

Warnings

Warnings
For external use only
Do not use

    * in or near the eyes
    * by putting directly into the rectum by using figers or any mechanical device
      or applicator
    * for diaper rash; ask a doctor

Dosage & Administration

Directions

  • apply to affected area not more than 3 to 4 time daily
  • for external anal itching: when practical, clean area with mild soap and warm

Inactive Ingredient

Inactive ingredients
Cetyl alcohol, Buthylated hydroxytoluene, Glycerin, Glyceryl monostearate, Isopropyl myristate, Myreistoyl/palmitoyl/oxostearamide/arachamide MEA, Methylparaben, PEG-15 glyceryl stearate, Squalane, Stearic acid, Propylparaben, Purified water
Hydrocortosone

* Please review the disclaimer below.