cvs hemorrhoidal ointment

cvs hemorrhoidal ointment
SPL v3
SPL
SPL Set ID c59dcb2a-392b-670b-e053-2995a90a9682
Route
topical
Published
Effective Date 2021-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
petrolatum (74.9 g) phenylephrine (0.25 g) mineral oil (14 g)
Inactive Ingredients
cetyl alcohol laureth-23 benzoic acid propylparaben methylparaben yellow wax glycerin stearyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-06-28

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
  • difficulty in urination due to enlargement of the 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
Purpose

Vasoconstrictor

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.
  • 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 room temperature 20°-25°C (68°-77°F)
  • Do not use if tube seal is broken or missing

Questions? Call 1-888-296-9067

Inactive Ingredients

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

Description

Phenylephrine HCI 0.25%

Packaging

Active Ingredient

Phenylephrine HCI 0.25%

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

Warnings

For external and/or anorectal use only

Ask 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 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
Purpose

Vasoconstrictor

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.
  • 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 room temperature 20°-25°C (68°-77°F)
  • Do not use if tube seal is broken or missing

Questions? Call 1-888-296-9067

Inactive Ingredients

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

Packaging

Active Ingredient

Phenylephrine HCI 0.25%

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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