Hydrocortisone Ointment
FDA Label NDC 45802-276

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Padagis Israel Pharmaceuticals Ltd for the product Hydrocortisone (NDC 45802-276). 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, 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.

Label Section Quick Index

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • 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. Ask a doctor.
  • for the treatment of diaper rash. Ask a doctor.

When Using This Product

  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by 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, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

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: do not use, 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 at 20°-25°C (68°-77°F)

Inactive Ingredients

aloe barbadensis leaf juice, white petrolatum

Questions Or Comments?

1-800-719-9260

Principal Display Panel

Relieves Itch Fast

Water Resistant Formula Helps Protect Skin

Skin Irritation

Inflammation & Redness

Rashes

Insect Bites

Eczema & Psoriasis

Compare to Cortizone – 10®

active ingredient

Hydrocortisone 1%

Maximum Strength Anti-Itch Ointment

NET WT 1 OZ (28 g)

471-rt-hydrocortisone-1.jpg (471 Rt Hydrocortisone 1)

471-rt-hydrocortisone-1.jpg (471 Rt Hydrocortisone 1)

471-rt-hydrocortisone-2.jpg (471 Rt Hydrocortisone 2)

471-rt-hydrocortisone-2.jpg (471 Rt Hydrocortisone 2)

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