FDA Label for Curist Hemorrhoid Fissure Relief

View Indications, Usage & Precautions

OTC - ACTIVE INGREDIENT
OTC - PURPOSE
WARNINGS
INDICATIONS & USAGE
OTC - ASK DOCTOR
OTC - ASK DOCTOR/PHARMACIST
OTC - WHEN USING
OTC - PREGNANCY OR BREAST FEEDING
OTC - STOP USE
OTC - KEEP OUT OF REACH OF CHILDREN
OTHER SAFETY INFORMATION
DOSAGE & ADMINISTRATION
STORAGE AND HANDLING
INACTIVE INGREDIENT
OTC - QUESTIONS
OTHER
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Curist Hemorrhoid Fissure 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.

Otc - Active Ingredient

Active Ingredients

Glycerin 14.4%

Lidocaine 5%

Petrolatum 15%

Phenylephrine HCL 0.25%

Otc - Purpose

Purpose

Hemorrhoidal Cream

Warnings

For external use only

Indications & Usage

Uses

for the temporary reliedf of pain, soreness and burning
helps relieve the local itching and discomfort associated with hemorrhoids
temporarily shrinks hemorrhoidal tissue
temporarily provides a coating for the relief of anorectal discomforts
temporarily protects the inflamedm irritated abirectak syrface to help make bowel movements less painful

Otc - Ask Doctor

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
difficult in urination due to the enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are presently taking a prescripton drug for high blood preassure or depression

Otc - When Using

When using this product

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Stop Use

Stop use and ask a doctor if

rectal bleeding occurs
condition worsens or does not imporve within seven (7) days
allergic reaction occurs to ingredients in this product
symptom being treated does not subside or if redness, irritation, swelling, pain or thor symptons develop or increase

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Safety Information

If swallowed, get medical help or contact a Poison Control Center right sway (1-800-222-1222)

Dosage & Administration

Directions

children under 12 years of age: consult a doctor
adults: when practical, cleanse area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying
apply externally to the affected area up to 4 times daily, especially at night, in the moring or after each bowel movement

Storage And Handling

Other information

store at 15° - 30°C (59°-86°F)

Inactive Ingredient

Inactive Ingredients

aloe barbadensis leaf extract, BHA, cellulose gum, cetyl alcohol, citric acid, disodium EDTA, ethylhexylglycerin, glyceryl stearate, mineral oil, panthenol, phenoxyethanol, propyl gallate, propylene glycol, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, zanthan gum

Otc - Questions

Questions? Call 1-844-243-1241 or email [email protected]

Other

Made in USA With Globally Sourced Ingedients

NDC 72559-037-08

REV 037-08-01

Distributed by: Little Pharma, Inc.

New York, NY 10023

Package Label.Principal Display Panel

curist

Hemorrhoid & Fissure Relief

Glycerin 14.%