FDA Label for Family Wellness Hemorrhoidal
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- 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
Family Wellness Hemorrhoidal Product Label
The following document was submitted to the FDA by the labeler of this product Family Dollar Services, 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
Drug Facts
Active ingredients Purposes
Mineral oil 14.0%.....................................................................Skin protectant
Petrolatum 74.9%....................................................................Skin protectant
Phenylephrine HCI 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 - Do Not Use
Do not use this product if you have
- heart disease
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- diabetes
Otc - Ask Doctor
Ask a doctor of pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
Otc - When Using
When using this product do not exceed the recommended daily dosage unless directed by a doctor
Otc - Stop Use
Stop use and ask a doctor if
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- introduction of applicator into the rectum causes additional pain
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional 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 (1-800-222-1222) right away.
Indications & Usage
Directions
- 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 ointment.
- when first opening the tube, peel back foil seal
- apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- FOR INTRARECTAL USE: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into rectum. Thoroughly clean applicator after each use and replace cover. Also apply ointment to external area.
- regular use provides continue therapy for relief of symptoms
- children under 12 years of age: ask a doctor
Storage And Handling
Other information store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients alcohol, alpha tocopherol acetate, glycerin, lanolin, methylparaben, polysorbate 80, propylparaben, purified water, stearyl alcohol, thyme oil, white wax
Dosage & Administration
Distributed by: Midwood Brands, LLC
500 Volvo Pkwy, Chesapeake, VA 23320 USA
Made in China
Package Label.Principal Display Panel
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