Your browser does not support JavaScript! HEALTHY ACCENTS HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [DZA BRANDS LLC]
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HEALTHY ACCENTS HEMORRHOIDAL (mineral oil, petrolatum, phenylephrine hcl) ointment
[DZA Brands LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredients

Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCl 0.25%

Purposes

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
difficulty in urination due to 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. (1-800-222-1222)

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 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

Other information

store at 20-25oC (68-77oF)

Inactive ingredients

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, shark liver oil, thymus vulgaris (thyme) oil, tocopheryl acetate, white wax

Questions or comments?

1-866-322-2439

Package/Label Principal Display Panel

Compare to Preparation H® Hemorrhoidal Ointment active ingredients

hemorrhoidal ointment

prevents further irritation

prompt soothing relief from painful burning, itching & discomfort

shrinks swollen hemorrhoidal tissue

protects irritated tissue

relieves internal and external discomfort

Hemorrhoidal Ointment Carton Image 1
Hemorrhoidal Ointment Carton Image 2
HEALTHY ACCENTS HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine hcl ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55316-678
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL140.000 mg  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM719.000 mg  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.500 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
CORN OIL 
GLYCERIN 
LANOLIN 
LANOLIN ALCOHOLS 
METHYLPARABEN 
PARAFFIN 
PROPYLPARABEN 
WATER 
SHARK LIVER OIL 
THYME OIL 
.ALPHA.-TOCOPHEROL ACETATE 
WHITE WAX 
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-678-161 in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34610/24/2012
Labeler - DZA Brands LLC (090322194)

Revised: 2/2013
 
DZA Brands LLC

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