FDA Label for Family Wellness
View Indications, Usage & Precautions
Family Wellness Product Label
The following document was submitted to the FDA by the labeler of this product Front Pharmaceutical Plc. 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 (in each gram)
Mineral oil 14%
Petrolatum 74.9%
Phenylephrine HCl 0.25%
Otc - Purpose
Purposes
Protectant
Protectant
Vasoconstrictor
Indications & Usage
Uses •helps relieve the local itching and discomfort associated with hemorrhoids.
•Temporarily shrinks hemorrhoid tissue and relieves burning.
•Temporarily provides a coating for relief of anorectal burning.
•Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less
painful
Warnings
Warnings
For external and/or intrarectal use only
Ask a doctor before use if you have
•heart disease •high blood pressure •thyroid disease •diabetes •trouble urinating due to
an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure.
Stop use and ask a doctor if
•bleeding occurs •condition worsens or does not improve within 7 days.
•introduction of the applicator into the rectum causes additional pain.
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 right
away.
Dosage & Administration
Directions
Adults and children 12 years of age and older for topical use:
•clean the affected area, and pat or dab dry before applying ointment.
•apply to the affected area up to 4 times daily, especially after each bowel movement.
For intrarectal use:
•attach included applicator to tube.
•lubricate applicator tip and gently insert into rectum
•thoroughly clean applicator after each use, and replace cover
Children under 12 years of age: ask a doctor before use.
Other Safety Information
Other information store at room temperature 68° - 77° F (20°-25° C).
Inactive Ingredient
Inactive ingredients beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23,
methylparaben, propylparaben, stearyl alcohol
Otc - Questions
Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST
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