Hydrocortisone
FDA Label NDC 61010-4402

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America, Inc. for the product Hydrocortisone (NDC 61010-4402). 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 ingredients, purpose, uses, warnings, otc - pregnancy or breast feeding, do not use, 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

Active Ingredients

Hydrocortisone USP 1%

Purpose

Antipruritic (Anti-itch)

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching

Warnings

For external use only

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use

Do Not Use

  • In the eyes
  • For diaper rash
  • For external genital or feminine itching if you have a vaginal discharge
  • More than the recommended daily dosage unless directed by a doctor
  • This product in 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 use of any other hydrocortisone product unless you have asked a doctor
  • In case of bleeding when used for anal itching

Otc - 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

Directions

  • 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
  • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching

Other Information

  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Soft Paraffin

Principal Display Panel - 1 Oz. Tube Label

Safetec®

1% Hydrocortisone Cream

For Itching, Inflammation, and Rashes

Net Wt. 1oz. (28.4g)

Reorder No. 53111

Manufactured for: Safetec of America, Inc.
Buffalo, NY 14215 | 1-800-456-7077
Made In India KD/503

Principal Display Panel (1 oz. Tube Label)

Principal Display Panel (1 oz. Tube Label)

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