best choice hemorrhoidal ointment

best choice hemorrhoidal ointment
SPL v2
SPL
SPL Set ID fe18fa61-83f9-8bf9-e053-6294a90a7585
Route
topical
Published
Effective Date 2023-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
mineral oil (14 g) petrolatum (74.9 g) phenylephrine (0.25 g)
Inactive Ingredients
benzoic acid propylparaben methylparaben yellow wax glycerin laureth-15 stearyl alcohol cetyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-06-01

Purpose

Vasoconstrictor

Description

Phenylephrine HCI 0.25%


Medication Information

Warnings

For external and/or anorectal 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 are presently taking a prescription drug for high blood pressure or depression

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 profects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • Introduction of applicator into the rectum causes additional pain
Purpose

Vasoconstrictor

Directions

Children under 12 years of age: ask a doctor before use.

Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe

  • Gently dry by patting or blotting with a tissue or soft cloth before applying
  • When first opening tube, remove foil seal
  • For intrarectal use: remove protective cover from applicator and attach to tube
  • Lubricate applicator well, then gently insert applicator into rectum
  • Thoroughly clean applicator and replace protective cover after each use
  • Clean the affected area and pat or dab dry before applying ointment
  • Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • also apply ointment to external area.
Other Information
  • Store at room temperature 20°-25°C (68°-77°F)
Inactive Ingredients

Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol

Description

Phenylephrine HCI 0.25%

Section 51945-4

Questions

Call 1-800-883-0085

Distributed By

Proudly Distributed by

Assocated wholesale grocers inc

kansas city Kansas 66106

Call 1 844 2921112 for product information

www.bestchoicebrand.com

Preparation H is a registered trademark of Glaxosmithkline consumer healthcare holdings US

Active Ingredient

Phenylephrine HCI 0.25%

When Using This Product

When using this product do not exceed the recommended dosage unless directed by a doctor

Stop Use and Ask Doctor If
  • Bleeding occurs
  • Condition worsens or does not improve within 7 days
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

Warnings

For external and/or anorectal 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 are presently taking a prescription drug for high blood pressure or depression

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 profects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • Introduction of applicator into the rectum causes additional pain
Purpose

Vasoconstrictor

Directions

Children under 12 years of age: ask a doctor before use.

Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe

  • Gently dry by patting or blotting with a tissue or soft cloth before applying
  • When first opening tube, remove foil seal
  • For intrarectal use: remove protective cover from applicator and attach to tube
  • Lubricate applicator well, then gently insert applicator into rectum
  • Thoroughly clean applicator and replace protective cover after each use
  • Clean the affected area and pat or dab dry before applying ointment
  • Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • also apply ointment to external area.
Other Information
  • Store at room temperature 20°-25°C (68°-77°F)
Inactive Ingredients

Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol

Section 51945-4 (51945-4)

Questions

Call 1-800-883-0085

Distributed By

Proudly Distributed by

Assocated wholesale grocers inc

kansas city Kansas 66106

Call 1 844 2921112 for product information

www.bestchoicebrand.com

Preparation H is a registered trademark of Glaxosmithkline consumer healthcare holdings US

Active Ingredient

Phenylephrine HCI 0.25%

When Using This Product (When using this product)

When using this product do not exceed the recommended dosage unless directed by a doctor

Stop Use and Ask Doctor If (Stop Use and Ask Doctor if)
  • Bleeding occurs
  • Condition worsens or does not improve within 7 days
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


Advanced Ingredient Data


Raw Label Data

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