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  5. Label Information: Apj Hemorrhoidal

FDA Label for Apj Hemorrhoidal

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT

Apj Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product A P J Laboratories Limited. 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



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


* Please review the disclaimer below.