APJ HEMORRHOIDAL- phenylephrine hydrochloride, mineral oil, petrolatum ointment

APJ HEMORRHOIDAL by

Drug Labeling and Warnings

APJ HEMORRHOIDAL by is a Otc medication manufactured, distributed, or labeled by A P J Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PHENYLEPHRINE HYDROCHLORIDE

PETROLATUM

MINERAL OIL

PURPOSE

Protectant

Vasoconstrictor

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

DISPLAY PANEL

INGREDIENTS AND APPEARANCE

APJ HEMORRHOIDAL 
phenylephrine hydrochloride, mineral oil, petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46084-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.55 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	720 mg  in 1 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	140 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)	40 mg  in 1 g
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)	70 mg  in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T)	.1 mg  in 1 g
PROPYLPARABEN (UNII: Z8IX2SC1OH)	.1 mg  in 1 g
CHLOROCRESOL (UNII: 36W53O7109)	.02 mg  in 1 g
LANOLIN (UNII: 7EV65EAW6H)	.5 mg  in 1 g
MAGNESIUM STEARATE (UNII: 70097M6I30)	1 mg  in 1 g
LIGHT MINERAL OIL (UNII: N6K5787QVP)	10 mg  in 1 g

Product Characteristics
Color	white (OFF WHITE)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46084-111-10	28 g in 1 TUBE
2	NDC: 46084-111-20	57 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/01/2013

Labeler - A P J Laboratories Limited (677378339)

Registrant - A P J Laboratories Limited (677378339)

Establishment
Name	Address	ID/FEI	Business Operations
A P J Laboratories Limited		677378339	manufacture(46084-111)