FDA Label for Quality Choice Hemorrhoidal
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Quality Choice Hemorrhoidal Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association 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 Purpose
Mineral oil 14% .................................................................Protectant
Petrolatum 71.9% .............................................................Protectant
Phenylephrine HCL 0.25% .................................................Vasoconstrictor
Shark liver oil 3.0%
...........................................................Protectant
Otc - Purpose
Uses
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue and relieves burning
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects the inflamed, irritated anorectal surface to help make
bowel movements less painful
Warnings
Warnings
For external and/or intrarectal use only
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are now taking a
prescription drug for high blood pressure or depression
Otc - When Using
When using this product do not use more than the recommended
daily dosage
Otc - Stop Use
Stop use and ask a doctor if
- bleeding occurs
- condition gets worse or does not get better within 7 days
- introduction of the applicator into the rectum causes additional
pain
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a physician before
use.
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.
Indications & Usage
Directions
- children under 12 years of age: ask a doctor
- adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe
- gently dry by patting or blotting with a tissue or a soft cloth before applying
- when first opening tube, remove foil seal
- for intrarectal use: remove protective cover form applicator and attach to
tube
- lubricate applicator well, then gently insert applicator into the rectum
- thoroughly clean applicator and replace protective cover after each use
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- also apply ointment to external area
Storage And Handling
Other information
Store at 20o to 25oC (68o to 77oF)
Inactive Ingredient
Inactive ingredients
benzoic acid, BHA, BHT, methylparaben, paraffin, propylparaben, thyme oil,
glyceryl stearate, glycerin, absorb refined lanoline, purified
water
Dosage & Administration
DISTRIBUTED BY QUALITY CHOICE
NOVI, MI 48376-0995
QC 95128
www.qualitychoice.com
Made in Korea
Package Label.Principal Display Panel
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