Quality Choice Hemorrhoidal Ointment

Quality Choice Hemorrhoidal Ointment
SPL v1
SPL
SPL Set ID 2b490a08-149d-76ab-e063-6394a90a084f
Route
TOPICAL
Published
Effective Date 2024-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (0.25 g) Mineral Oil (14 g) Petrolatum (74.9 g)
Inactive Ingredients
Stearyl Alcohol Benzoic Acid Cetyl Alcohol Laureth-23 Methylparaben Yellow Wax Glycerin Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-14

Description

Phenylephrine HCI 0.25%

Purpose

Vasoconstrictor


Medication Information

Purpose

Vasoconstrictor

Description

Phenylephrine HCI 0.25%

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 doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

Ask doctor before use if you arepresently taking a prescription drug for high blood pressure.

Packaging

Directions
  • Adults and children 12 years of age and older for topical use:
  • Clean the affected area and pat or dab dry before applying ointment.
  • apply to the affected area up to 4 times daily, especially after each bowel movement.
  • attach included applicator to tube
  • lubricate applicator tip and gently insert into the rectum.
  • thoroughly clean applicator after each use and replace cover.
  • Children under 12 years of age; ask doctor before use
Distributed By

Distributed By CDMA Inc.

43157 W 9 Mile Road

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Product of PRC

This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H.

Active Ingredient

Phenylephrine HCI 0.25%

Other Information
  • Store at room temperature 20º-25ºC (68º-77ºF)
Inactive Ingredients

Beeswax, Benzoic Acid, Cetyl alcohol, Glycerin, Methylparaben, Laureth-23, Propylparaben, Stearyl alcohol

Ask Doctor Before Use

Ask doctor before use if you are presently taking a prescription drug for high blood pressure.

Ask doctor before use if you have:

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Questions Or Comments?

1-800-935-2362

Stop Use and Ask 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 doctor before use

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.


Structured Label Content

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
Purpose

Vasoconstrictor

Warnings

For external and/or intrarectal use only

Ask doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

Ask doctor before use if you arepresently taking a prescription drug for high blood pressure.

Packaging

Directions
  • Adults and children 12 years of age and older for topical use:
  • Clean the affected area and pat or dab dry before applying ointment.
  • apply to the affected area up to 4 times daily, especially after each bowel movement.
  • attach included applicator to tube
  • lubricate applicator tip and gently insert into the rectum.
  • thoroughly clean applicator after each use and replace cover.
  • Children under 12 years of age; ask doctor before use
Distributed By

Distributed By CDMA Inc.

43157 W 9 Mile Road

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Product of PRC

This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H.

Active Ingredient

Phenylephrine HCI 0.25%

Other Information
  • Store at room temperature 20º-25ºC (68º-77ºF)
Inactive Ingredients

Beeswax, Benzoic Acid, Cetyl alcohol, Glycerin, Methylparaben, Laureth-23, Propylparaben, Stearyl alcohol

Ask Doctor Before Use (Ask doctor before use)

Ask doctor before use if you are presently taking a prescription drug for high blood pressure.

Ask doctor before use if you have:

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Questions Or Comments? (Questions or Comments?)

1-800-935-2362

Stop Use and Ask Doctor If (Stop Use and Ask 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 (If Pregnant or breast-feeding)

Ask a doctor before use

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed get medical help or contact a Poison Control Center right away.


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Raw Label Data

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