Rrhoid Rage Hemorrhoidal Ointment

Rrhoid Rage Hemorrhoidal Ointment
SPL v1
SPL
SPL Set ID a02a6398-0acd-4aa7-8320-ac586ff12eb3
Route
TOPICAL
Published
Effective Date 2024-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Butylated Hydroxyanisole Glycerin Lanolin Alcohols Magnesium Sulfate, Unspecified Form Methylparaben Mineral Oil Petrolatum Propylparaben Witch Hazel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-12

Description

Lidocaine 4% Phenylephrine HCL 0.25%

Purpose

Local Anesthetic Vasoconstrictor


Medication Information

Purpose

Local Anesthetic

Vasoconstrictor

Description

Lidocaine 4% Phenylephrine HCL 0.25%

Uses

–Helps relieve the pain, itching, and burning associated with hemorrhoids.

–Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.

–Temporarily provides a coating for relief of anorectal discomforts.

–Temporarily protects irritated areas and inflamed perianal skin.

Warnings

For external use only.

Directions

–When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.

–Adults and children 12 years and older: apply externally to the affected area up to 4 times daily.

–Children under 12 years of age: consult a doctor.

Drug Facts

Other Information

–Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F).

Package Labeling:

Active Ingredients

Lidocaine 4%

Phenylephrine HCL 0.25%

Inactive Ingredients

aloe extract AQ, balsam fir, butylated hydroxyanisol, glycerin, lanolin alcohols, lanolin USP, magnesium sulfate, methyl paraben, mineral oil, petrolatum, propylparaben, witch hazel, white bees wax.

When Using This Product

–Avoid contact with eyes.

–Do not exceed recommended daily dosage unless directed by a doctor.

–Do not put this product 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.

–Allergic reaction occurs to ingredients in this product.

–Symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

If Pregnant Or Breastfeeding,

ask a doctor 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.

–Difficulty 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

Uses

–Helps relieve the pain, itching, and burning associated with hemorrhoids.

–Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.

–Temporarily provides a coating for relief of anorectal discomforts.

–Temporarily protects irritated areas and inflamed perianal skin.

Purpose

Local Anesthetic

Vasoconstrictor

Warnings

For external use only.

Directions

–When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.

–Adults and children 12 years and older: apply externally to the affected area up to 4 times daily.

–Children under 12 years of age: consult a doctor.

Drug Facts

Other Information (Other information)

–Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F).

Package Labeling:

Active Ingredients

Lidocaine 4%

Phenylephrine HCL 0.25%

Inactive Ingredients (Inactive ingredients)

aloe extract AQ, balsam fir, butylated hydroxyanisol, glycerin, lanolin alcohols, lanolin USP, magnesium sulfate, methyl paraben, mineral oil, petrolatum, propylparaben, witch hazel, white bees wax.

When Using This Product (When using this product)

–Avoid contact with eyes.

–Do not exceed recommended daily dosage unless directed by a doctor.

–Do not put this product 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.

–Allergic reaction occurs to ingredients in this product.

–Symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

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.

Ask A Doctor Before Use If You Have: (Ask a 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 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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Raw Label Data

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