Procure Ointment
FDA Label NDC 55681-224

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Twin Med, Llc for the product Procure (NDC 55681-224). 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 (per gram), purpose, uses, warnings, do not use, ask a doctor before use if, 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 (Per Gram)

Hydrocortisone Acetate, USP (1% w/w)

Purpose

Antipruritic (Anti-Itch)


Uses

For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external gential, feminine and anal 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 eyes
  • for diaper rash
  • if you have vaginal discharge
  • more than recommended dosage.

Ask A Doctor Before Use If

you are pregnant or breast feeding

Stop Use And Ask A Doctor If

  • the condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children

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

Directions

  • Adults and children over 2 years of age
  • Apply evenly to affected area no more than 3 to 4 times daily
  • Children under 2 years of age
  • Do not use, consult a doctor
  • Adults- When practical, 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
  • apply externally to the area up to 6 times daily or after bowel movment
  • After application, discard pad. Do not flush in toilet.

Other Information

  • Store at 20o-25oC(68o-77o F)
  • Avoid excessive heat and humidity.

Inactive Ingredients

Cetomacrogol 1000, Cetostearyl Alcohol, Chloracresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin.

Principal Display Panel

NDC # 55681-224-02

ProCure

HYDROCORTISONE 1% CREAM

Relief of Minor Skin Irritations, Itching and Rashes

144 PACKETS

Net Weight: 0.9 grams

Item No. PCHC09

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