Hydrocortisone
FDA Label NDC 68071-2818

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nucare Pharmaceuticals,inc. for the product Hydrocortisone (NDC 68071-2818). 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 other, active ingredient, purpose, uses, warnings, do not use, 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

Other

Drug Facts

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

Active Ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
    • eczema
    • psoriasis
    • insect bites
    • poison ivy, oak, sumac
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
    • temporarily relieves external anal and genital itching
    • other uses of this product should be 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. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.

When Using This Product

  • avoid contact with the eyes
  • do not use more than directed unless directed 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
  • do not begin the use of any other hydrocortisone product unless directed by a doctor
  • rectal bleeding occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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: consult a doctor
    • for external anal and genital itching
      • adults: when practical, clean the affected 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
      • apply to affected area not more than 3 to 4 times daily
      • children under 12 years of age: consult a doctor

Other Information

  • store at 15°-30°C (59°-86°F). Protect from freezing.
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients

cetyl alcohol, citric acid

Contains one or more of these ingredients to adjust pH

, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution , sorbic acid, sorbitan monostearate, stearyl alcohol, white wax

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