Hemorrhoidal
FDA Label NDC 63941-202

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Valu Merchandisers, Co. for the product Hemorrhoidal (NDC 63941-202). 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 uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Uses

→ Warnings

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Active Ingredients

→ Purpose

→ Questions Or Comments?

→ Package Label

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

For external use only 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 enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug for high blood pressure or depression.

When Using This Product

do not exceed the recommended daily dosage unless directed by a doctor.

Stop Use And Ask A Doctor If

bleeding occurs
condition worsens or does not improve within 7 days
introduction of 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: 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 tube, puncture foil seal with top end of cap
apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
intrarectal use: remove cover form applicator and attach tube, lubricate applicator well, then gently insert applicator into the rectum - thoroughly cleanse applicator after each use and replace cover
also apply ointment to external area
regular use provides continual therapy for relief of symptoms
children under 12 years of age: ask a doctor

Other Information

Other information

Store at 20 ^o to 25 ^oC (68 ^o to 77 ^oF)

Inactive Ingredients

beeswax, benzoic acid, cetyl alcohol, blyerol, methylparaben, polyoxyethylene lauryl ether, propylparaben, stearyl alcohol

Active Ingredients

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCL 0.25%

Purpose

Protectant

Vasoconstrictor

Questions Or Comments?

Call toll free: 1-800-883-0085

Package Label

Best Choice Hemorrhoidal Ointment

Carton (20161 Bc Hemorrhoidal Ointment)

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