Hydrocortisone
FDA Label NDC 29500-2439

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Personal Care Products, Inc. for the product Hydrocortisone (NDC 29500-2439). 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, keep out of reach of children, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Drug Facts

Hydrocortisone 1%

Purpose

Anti itch

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.

Uses

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

  • eczema
  • inset bites
  • cosmetics
  • psoriasis
  • detergents
  • soaps
  • poison ivy, oak
  • sumac
  • jewelry
  • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

  •  in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor


    • When using this product

    • avoid contact with eyes
    • do not use more than directed unless told to do so by a doctor
    • do not put directly into the rectum


      • Stop use and ask a doctor if

      • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

Directions

  • for itching of skin irritation, inflammation, and rashes: 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: ask a doctor
    • for external anal and genital itching: adults - when practical, clean 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 applying - apply to affected area not more than 3 to 4 times daily - children under 12 years of age: ask a doctor

Other Information

  • store between 59° and 86° F  (15° and 30° C)
  • do not use if seal on tube is punctured or missing

Inactive Ingredients

aloe vera gel, celeareth-20, cetyl alcohol, cetyl palitate, glycerin, isopropyl myristate, isodecyl neopentanoate, methyl paraben, purified water

Product Label

DRUGSTORE-Rx

SMART WELLNESS

Ultra Strength

Hydrocortisone Cream

Fast Itch and Rash relief

Helps relieve

  • Eczema
  • Seborrheic dermatitis
  • Psoriasis
  • Poison ivy
  • Poison oak
  • Poison sumac
  • Insect bites and more


    • NET WT. 0.5 OZ. (14 g)

    Distributed by: PERSONAL CARE PRODUCTS, LLC  Troy, Michigan 48084 U.S.A.

    Code No.:MH/DRUGS/KD-313      Made in India


    Pc Hydrocortisone1 Label (Pc Hydrocortisone1)

    Pc Hydrocortisone1 Label (Pc Hydrocortisone1)

    Pc Hydrocortisone4 Label (Pc Hydrocortisone4)

    Pc Hydrocortisone4 Label (Pc Hydrocortisone4)







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