Otc - Active Ingredient
Active ingredients (in each gram)
Mineral oil 14%
Petrolatum 74.9%
Phenylephrine HCl 0.25%
The following Structured Product Label (SPL) was submitted to the FDA by Front Pharmaceutical Plc for the product Family Wellness (NDC 69571-006). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each gram)
Mineral oil 14%
Petrolatum 74.9%
Phenylephrine HCl 0.25%
Purposes
Protectant
Protectant
Vasoconstrictor
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
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right
away.
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 information store at room temperature 68° - 77° F (20°-25° C).
Inactive ingredients beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23,
methylparaben, propylparaben, stearyl alcohol
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