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  5. Label Information: Curist Hemorrhoid Relief

FDA Label for Curist Hemorrhoid Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Curist Hemorrhoid Relief Product Label

The following document was submitted to the FDA by the labeler of this product Little Pharma, Inc.. 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.

Other



Drug Facts

Distributed by:

Little Pharma, Inc.

New York, NY 10023

Made in USA With Globally Sourced Ingredients


Otc - Active Ingredient



Active ingredient

Lidocaine 5%


Otc - Purpose



Purpose

Anorectal (hemorrhoidal) cream


Indications & Usage



Uses

Helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders.


Warnings



Warnings

For external use only.


Otc - When Using



When using this product

  • avoid contact with eyes.
  • do not exceed recommended dosage unless directed by a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Otc - Stop Use



Stop use and ask a doctor if

  • rectal bleeding occurs.
  • condition worsens or does not improve within 7 days.
  • allergic reaction occurs to ingredients in this product.
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
  • symptoms clear up and return within a few days.

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.


Dosage & Administration



Directions

  • 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 soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.

Storage And Handling



Other information

Store at 15-30°C (59-86°F)


Inactive Ingredient



Inactive ingredients Benzyl alcohol, carbomer, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate, triethanolamine, water.


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