FDA Label for Major Prep 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
Major Prep Hemorrhoidal Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. 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 74.9%............................................................Protectant
Phenylephrine HCl 0.25%..........................................Vasoconstrictor
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 of 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 exceed 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 from 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 20° to 25°C (68° to 77°F)
Inactive Ingredient
Inactive ingredients glycerin, lanolin, methylparaben, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax
Dosage & Administration
Distributed By
Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150
Made in Korea
Package Label.Principal Display Panel
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