Revivol Hemorrhoid And Fissure Cream

Revivol Hemorrhoid And Fissure Cream
SPL v2
SPL
SPL Set ID 0140cf68-b6a0-4378-e063-6394a90afee8
Route
TOPICAL
Published
Effective Date 2023-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g) Petrolatum (15 g) Glycerin (14.4 g) Phenylephrine (0.25 g)
Inactive Ingredients
Calendula Officinalis Flower Hamamelis Virginiana Leaf Horse Chestnut Centella Asiatica Triterpenoids Xanthan Gum Mineral Oil Phenoxyethanol .alpha.-tocopherol Acetate Cetyl Alcohol Citric Acid Monohydrate Edetate Disodium Panthenol Butylated Hydroxyanisole Aloe Vera Leaf Sorbitan Olivate Steareth-21 Water Ethylhexylglycerin Glyceryl Monostearate Propyl Gallate Propylene Glycol Carboxymethylcellulose Sodium Stearyl Alcohol Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-12

Description

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%


Medication Information

Warnings and Precautions

For external and/or intrarectal use.

Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, or 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.

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

Stop use and ask a doctor if condition worsens or does not improve within seven (7) days, bleeding occurs, an allergic reaction develops, the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

Indications and Usage

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

Dosage and Administration

Adults: when practical, cleanse area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. 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: consult a doctor.

For intrarectal use: attach applicator to tube. Lubricate well, then gently insert applicator into the rectum. Thoroughly cleanse applicator after use with mild soap and warm water and rinse thoroughly.

Description

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%

Section 50565-1

If swallowed, seek medical help or contact a Poison Control Center right away.

Section 51727-6

Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, BHA, calendula officinalis extract, cellulose gum, centella asiatica extract, cetyl alcohol, citric acid, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hamamelis virginiana (witch hazel) leaf extract, mineral oil, panthenol, phenoxyethanol, propyl gallate, propylene glycol, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, xanthan gum.

Section 51945-4

Section 53414-9

Ask a health care professional before use.

Section 55105-1

Anorectal/Hemorrhoidal

Section 55106-9

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Adults: when practical, cleanse area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. 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: consult a doctor.

For intrarectal use: attach applicator to tube. Lubricate well, then gently insert applicator into the rectum. Thoroughly cleanse applicator after use with mild soap and warm water and rinse thoroughly.

Warnings and Precautions (34071-1)

For external and/or intrarectal use.

Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, or 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.

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

Stop use and ask a doctor if condition worsens or does not improve within seven (7) days, bleeding occurs, an allergic reaction develops, the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

Section 50565-1 (50565-1)

If swallowed, seek medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, BHA, calendula officinalis extract, cellulose gum, centella asiatica extract, cetyl alcohol, citric acid, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hamamelis virginiana (witch hazel) leaf extract, mineral oil, panthenol, phenoxyethanol, propyl gallate, propylene glycol, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, xanthan gum.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Ask a health care professional before use.

Section 55105-1 (55105-1)

Anorectal/Hemorrhoidal

Section 55106-9 (55106-9)

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%


Advanced Ingredient Data


Raw Label Data

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