83887-009

83887-009
SPL v2
SPL
SPL Set ID 37589041-7c55-7435-e063-6394a90afa1b
Route
TOPICAL
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Dimethicone Steareth-21 Methylparaben Mineral Oil Petrolatum Propylene Glycol Steareth-2 Iodopropynyl Butylcarbamate Glycerin Water Propylparaben Diazolidinyl Urea Cetostearyl Alcohol Laurocapram Allantoin Ammonium Methacrylate Isopropyl Myristate Rose Oil .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-12

Description

Lidocaine 5%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5%

Use

For temporary relief of local and anorectal itching, discomfort, and inflammation associated with anorectal disorders.

For temporary relief of pain, burning, and soreness.

Stop Use

Discontinue use and consult a doctor if symptoms persist or worsen, including redness, irritation, swelling, or pain due to possible allergies to product ingredients.

Warnings

1. If symptoms worsen or do not improve within 7 days, seek medical advice.

2. Do not exceed the recommended daily dosage without a doctor's instruction.

3. Consult a doctor immediately if bleeding occurs.

4. Do not insert this product into the rectum using fingers or any applicator.

5. Some people may be allergic to the ingredients. Discontinue use and consult a doctor if symptoms persist or worsen, including redness, irritation, swelling, or pain.



Note: Discontinue use and consult a doctor if symptoms persist or worsen, including redness, irritation, swelling, or pain due to possible allergies to product ingredients.

Ask Doctor

Discontinue use and consul a doctor if symptoms persist or worsen, including redness, iritaion. sweling, or pain due to possible

allergies to product ingredients

Directions

Adults: When practical.

cleanse theaffected area with mild soap andwarm water.

and rinse thoroughlyGently dry by patting or blotting withtoilet tissue or a soft cloth beforeapplication of this product

Do Not Use

Do not use this product if the seal is broken or missing.

When Using

If symptoms worsen or do not imorove within 7 davs

seek medicaladvice,Do not exceed the recommended daily dosage

Do not insert this product into the rectum using fingers or any applicator

Some peoole mav be aleroic to he inoredients, biscontinwe use and consut a doctor if symotoms persistor worsen including redness irtation swelina or nain

without doctor'sinstruction.Consult a doctor immediately if bleedina occurs

Active Ingredient

Lidocaine 5%

Other Information

Keep away from direct sunlight orheat

Store at room temperaturebetween 15°C to 30°C(59°F - 86°F))

This package is chld.resisiantKeep out ofreach of chidren.in case ofacidenlal overdose omgesion,cala ocororpoisonconr0. cemerimmediately. Do notuse this productifthe seals broken or mising

Inactive Ingredients

Vitamin E,Allantoin,Mineral Oil,Dimethicone,Methylparaben,Propylparaben,Petrolatum,IPBC,Diazolidinyl Urea,Glycerin,Cetostearyl Alcohol,Isopropyl Myristate,Propylene Glycol,Ammonium,Methacrylate,Purified Water,Laurocapram,Steareth-2,Steareth-21,Rose Oil

Principal Display Panel

Keep Out of Reach of Children

This package is child-resistant.Keep out of reach of children


Structured Label Content

Use

For temporary relief of local and anorectal itching, discomfort, and inflammation associated with anorectal disorders.

For temporary relief of pain, burning, and soreness.

Purpose

Local Anesthetic

Stop Use

Discontinue use and consult a doctor if symptoms persist or worsen, including redness, irritation, swelling, or pain due to possible allergies to product ingredients.

Warnings

1. If symptoms worsen or do not improve within 7 days, seek medical advice.

2. Do not exceed the recommended daily dosage without a doctor's instruction.

3. Consult a doctor immediately if bleeding occurs.

4. Do not insert this product into the rectum using fingers or any applicator.

5. Some people may be allergic to the ingredients. Discontinue use and consult a doctor if symptoms persist or worsen, including redness, irritation, swelling, or pain.



Note: Discontinue use and consult a doctor if symptoms persist or worsen, including redness, irritation, swelling, or pain due to possible allergies to product ingredients.

Ask Doctor

Discontinue use and consul a doctor if symptoms persist or worsen, including redness, iritaion. sweling, or pain due to possible

allergies to product ingredients

Directions

Adults: When practical.

cleanse theaffected area with mild soap andwarm water.

and rinse thoroughlyGently dry by patting or blotting withtoilet tissue or a soft cloth beforeapplication of this product

Do Not Use (Do not use)

Do not use this product if the seal is broken or missing.

When Using

If symptoms worsen or do not imorove within 7 davs

seek medicaladvice,Do not exceed the recommended daily dosage

Do not insert this product into the rectum using fingers or any applicator

Some peoole mav be aleroic to he inoredients, biscontinwe use and consut a doctor if symotoms persistor worsen including redness irtation swelina or nain

without doctor'sinstruction.Consult a doctor immediately if bleedina occurs

Active Ingredient

Lidocaine 5%

Other Information (Other information)

Keep away from direct sunlight orheat

Store at room temperaturebetween 15°C to 30°C(59°F - 86°F))

This package is chld.resisiantKeep out ofreach of chidren.in case ofacidenlal overdose omgesion,cala ocororpoisonconr0. cemerimmediately. Do notuse this productifthe seals broken or mising

Inactive Ingredients (Inactive ingredients)

Vitamin E,Allantoin,Mineral Oil,Dimethicone,Methylparaben,Propylparaben,Petrolatum,IPBC,Diazolidinyl Urea,Glycerin,Cetostearyl Alcohol,Isopropyl Myristate,Propylene Glycol,Ammonium,Methacrylate,Purified Water,Laurocapram,Steareth-2,Steareth-21,Rose Oil

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

This package is child-resistant.Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)