Family Wellness Ointment
FDA Label NDC 69571-006

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

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.

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

Package Label.Principal Display Panel

Image Description (Hemar 006)

Image Description (Hemar 006)

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