HEALTHY ACCENTS HEMORRHOIDAL - mineral oil, petrolatum, phenylephrine hydrochloride and shark liver oil ointment
DZA Brands LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCl 0.25%

Shark liver oil 3.0%

Purpose

Protectant

Vasoconstrictor

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 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 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 the 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. (1-800-222-1222)

Directions

adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad
gently dry by patting or blotting with toilet 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
for intrarectal use:
remove cover from applicator and attach applicator to tube
lubricate applicator well, then gently insert applicator into the rectum
thoroughly clean applicator after each use and replace cover
also apply ointment to external area
children under 12 years of age: ask a doctor

Other information

store at 68°-77°F (20°-25°C)

Inactive ingredients

beeswax, benzoic acid, BHA, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, purified water, thyme oil, tocopherol

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare to Preparation H® Hemorrhoidal Ointment active ingredients

Hemorrhoidal Ointment

Prompt Soothing Relief from Painful Burning, Itching and Discomfort

Shrinks Swollen Hemorrhoidal Tissue

Protects Irritated Tissue

Hemorrhoidal Ointment Carton Image 1

Hemorrhoidal Ointment Carton Image 2

HEALTHY ACCENTS HEMORRHOIDAL
mineral oil, petrolatum, phenylephrine hcl, shark liver oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55316-400
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (MINERAL OIL)	MINERAL OIL	14 g in 100 g
PETROLATUM (PETROLATUM)	PETROLATUM	71.9 g in 100 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g in 100 g
SHARK LIVER OIL (SHARK LIVER OIL)	SHARK LIVER OIL	3 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX
BENZOIC ACID
BUTYLATED HYDROXYANISOLE
CORN OIL
GLYCERIN
LANOLIN
METHYLPARABEN
PARAFFIN
PROPYLPARABEN
WATER
THYME OIL
ALPHA-TOCOPHEROL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:55316-400-16	1 TUBE ( TUBE) in 1 CARTON	contains a TUBE
1		57 g in 1 TUBE	This package is contained within the CARTON (55316-400-16)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	08/02/2010

Labeler - DZA Brands LLC (090322194)

Revised: 08/2010 DZA Brands LLC