Otc - Active Ingredient
Active Ingredients
Glycerin 14.4%
Lidocaine 5%
Petrolatum 15%
Phenylephrine HCL 0.25%
Curist Hemorrhoid Fissure Relief Cream
FDA Label NDC 72559-037
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Little Pharma, Inc for the product Curist Hemorrhoid Fissure Relief (NDC 72559-037). 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 otc - active ingredient, otc - purpose, warnings, indications & usage, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Hemorrhoidal Cream
Warnings
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.%
Lidocaine 5%
Petrolatum 15%
Phenylephrine HCL 0.25%
Hemorrhoidal Cream
Provides a Soothing Protective Layer
Temporary Relief of Pain,
Itching, adn Burning
Reduces Swelling
Net Wt. 6 oz (170g)
* Please review the disclaimer below.
