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  5. Label Information: Procure

FDA Label for Procure

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (PER GRAM)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL

Procure Product Label

The following document was submitted to the FDA by the labeler of this product Twin Med, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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