DZA Brands, LLC Hemorrhoidal Ointment Drug Facts

Healthy Accents Hemorrhoidal by

Drug Labeling and Warnings

Healthy Accents Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY ACCENTS HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hcl 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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DZA Brands, LLC Hemorrhoidal Ointment Drug Facts

Active ingredients

Mineral oil 14%

Petrolatum 74.9%

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 20-25°C (68-77°F)

Inactive ingredients

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, 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

NET WT 2 OZ (57g)

Healthy Accents Hemorrhoidal Ointment1
Healthy Accents Hemorrhoidal Ointment2
HEALTHY ACCENTS HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55316-188
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL14 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM74.9 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CORN OIL (UNII: 8470G57WFM)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
THYME OIL (UNII: 2UK410MY6B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WHITE WAX (UNII: 7G1J5DA97F)  
Product Characteristics
ColorYELLOW (light) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55316-188-161 in 1 CARTON10/30/201309/30/2019
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34610/30/201309/30/2019
Labeler - DZA Brands LLC (090322194)

Revised: 11/2019
 
DZA Brands LLC