Apj Hemorrhoidal
FDA Label NDC 46084-111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A P J Laboratories Limited for the product Apj Hemorrhoidal (NDC 46084-111). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

PETROLATUM

MINERAL OIL

Otc - Purpose


Protectant

Vasoconstrictor

Otc - Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

■ 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 and/or intrarectal use only


Dosage & Administration


■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, 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 from applicator, attach applicator to tube, lubricate applicator well and 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



Inactive Ingredient


PARAFFIN

BUTYLATED HYDROXYTOLUENE

METHYLPARABEN

PROPYLPARABEN

CHLOROCRESOL

LANOLIN

MAGNESIUM STEARATE

LIGHT MINERAL OIL

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