Hydrocortisone Cream
FDA Label NDC 71399-0180

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc for the product Hydrocortisone (NDC 71399-0180). 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, use, 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.

Active Ingredient

Hydrocortisone 1%

Purpose

Antipruritic (Anti-itch)

Use

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

  • eczema
  • insect bites
  • poison ivy or sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry,
  • seborrheic dermatitis
  • poison oak
  • psoriasis
  • temporarily relieves external anal and genital itching
  • Other uses of this product should be undertaken only 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.
  • for the treatment of diaper rash, Consult a doctor.

When Using This Product

  • avoid contact with eyes
  • do not use more thatn directed unless told to do so by a doctor
  • do not put directly into the rectumby using fingers or any mechanical device or applicator

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. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
  • rectal bleeding occurs.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222).

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, cleanse 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 at 20-25 C (68-77 F).

Inactive Ingredients

aloe vera, benzyl alcohol, glyceryl monostearate, mineral oil, PEG-40, PEG-25, propylene glycol, purified water, squalane, stearic acid.

Questions Or Comments?

Call toll-free 1-877-225-6999

Other

Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ 07004

www.akronpharma.com

Made in USA

Package Label.Principal Display Panel

454g (454g)

454g (454g)

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