Cvs Hemorrhoidal Ointment

Cvs Hemorrhoidal Ointment
SPL v3
SPL
SPL Set ID c50cc6ad-e8a0-47c1-e053-2a95a90a4de6
Route
TOPICAL
Published
Effective Date 2021-06-18
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 Stearyl Alcohol Cetyl Alcohol Laureth-23 Propylparaben Methylparaben Yellow Wax Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-18

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 profects the inflamed, irritated anorectal surface to help make bowel movements less painful
Section 51945-4

Warnings

For external and/or intrarectal use only

Ask doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty 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

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 with a soft cloth before applying ointment
  • 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 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
Distributed By

CVS Pharmacy Inc.

One CVS Drive

Woonsocket, RI 02895

©2020 CVS Pharmacy

CVS.com

1-800-SHOP CVS

Made in China

V-36582

CVS Quality Money Back guarantee

This product is not manufactured or distributed by Wyeth LLC, owner of registered trademark Preparation H®

Active Ingredient

Phenylephrine HCI 0.25%

Other Information
  • Store at room temperature 20°-25°C (68°-77°F)

Questions? Call 1-888-296-9067

Inactive Ingredients

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

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 (1-800-222-1222)


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 profects the inflamed, irritated anorectal surface to help make bowel movements less painful
Section 51945-4 (51945-4)

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
  • difficulty 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

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 with a soft cloth before applying ointment
  • 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 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
Distributed By

CVS Pharmacy Inc.

One CVS Drive

Woonsocket, RI 02895

©2020 CVS Pharmacy

CVS.com

1-800-SHOP CVS

Made in China

V-36582

CVS Quality Money Back guarantee

This product is not manufactured or distributed by Wyeth LLC, owner of registered trademark Preparation H®

Active Ingredient

Phenylephrine HCI 0.25%

Other Information
  • Store at room temperature 20°-25°C (68°-77°F)

Questions? Call 1-888-296-9067

Inactive Ingredients

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

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 (1-800-222-1222)


Advanced Ingredient Data


Raw Label Data

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