Hemorrhoidal Cream With Lidocaine

Hemorrhoidal Cream With Lidocaine
SPL v2
SPL
SPL Set ID 4d870c68-9e72-464e-b0b8-900d0d661e43
Route
TOPICAL
Published
Effective Date 2022-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (144 mg) Lidocaine (50 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Cetostearyl Alcohol Citric Acid Monohydrate Dexpanthenol Glyceryl Monostearate Methylparaben Mineral Oil Stearyl Alcohol Polysorbate 80 Propylene Glycol Water .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-01

Description

Glycerin 14.4% Lidocaine 5% Phenylephrine HCl 0.25% White petrolatum 15%

Purpose

Protectant Local anesthetic Vasoconstrictor Protectant


Medication Information

Purpose

Protectant

Local anesthetic

Vasoconstrictor

Protectant

Description

Glycerin 14.4% Lidocaine 5% Phenylephrine HCl 0.25% White petrolatum 15%

Use
  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • temporarily shrinks hemorrhoidal tissue
Warnings

For external use only.

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 this cream.
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: ask a doctor.
Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Other Information

store at room temperature 68° - 77° F (20° - 25° C)

Package Labeling:

Active Ingredients

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

Inactive Ingredients

aloe oil, cetearyl alcohol, citric acid monohydrate, dexpanthenol, ethylenediaminetetraacetic acid disodium salt, glyceryl monostearate, methylparaben, mineral oil, octadecyl alcohol, polysorbate 80, propyl 4-hydroxybenzoate, propylene glycol, purified water, vitamin E

When Using This Product
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If
  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
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.

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • diffficulty 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.


Structured Label Content

Use
  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • temporarily shrinks hemorrhoidal tissue
Purpose

Protectant

Local anesthetic

Vasoconstrictor

Protectant

Warnings

For external use only.

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 this cream.
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: ask a doctor.
Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Other Information (Other information)

store at room temperature 68° - 77° F (20° - 25° C)

Package Labeling:

Active Ingredients (Active ingredients)

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

Inactive Ingredients (Inactive ingredients)

aloe oil, cetearyl alcohol, citric acid monohydrate, dexpanthenol, ethylenediaminetetraacetic acid disodium salt, glyceryl monostearate, methylparaben, mineral oil, octadecyl alcohol, polysorbate 80, propyl 4-hydroxybenzoate, propylene glycol, purified water, vitamin E

When Using This Product (When using this product)
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • diffficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

presently taking a prescription drug for high blood pressure or depression.


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