83887-001

83887-001
SPL v1
SPL
SPL Set ID 0d27b90a-bd71-c1f5-e063-6394a90a22a0
Route
TOPICAL
Published
Effective Date 2023-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-22

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 adoctor if symptoms persist orworsen, including redness, irritation,swelling, or pain due to possibleallergies to product ingredients.

Warnings

lf symptoms worsen or do notimprove within 7 days, seek medicaadvice.

Do not exceed the recommendeodaily dosage without doctor's

instruction.

Consult a doctor immediately if bleeding occurs.

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

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 consult a doctor if symptoms persist or worsen, including redness, irritation. swelling, 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

Some people may be allergic tothe ingredients. Discontinue use andconsult a doctor if symptoms persistor worsen,including rednessirritation,swelling,or pain.

When Using

If symptoms worsen or do not improve within 7 days, seek medicaladvice.Do not exceed the recommended daily dosage without doctor'sinstruction.Consult a doctor immediately if bleeding occurs.

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

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

Active Ingredient

Lidocaine 5%

Other Information

Keep away from direct sunlight orheat.

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

This package is child-resistant.Keep out of reach of children. In case of accidental overdose oringestion, call a doctor or poisoncontrol center immediately. Do not use this product if the sealis broken or missing.

Inactive Ingredients

Vitamin E Allantoin, Mineral Oil.Dimethicone,MethylparabenPropylparaben, Petrolatum, IPBCDiazolidinyl Urea, Glycerin,Cetostearyl Alcohol, IsopropylMyristate, Propylene Glycol,Ammonium,Methacrylate, PurifiedWater, Laurocapram, Steareth-2.Steareth-21 Rose Oil

Principal Display Panel

Keep Oot 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 adoctor if symptoms persist orworsen, including redness, irritation,swelling, or pain due to possibleallergies to product ingredients.

Warnings

lf symptoms worsen or do notimprove within 7 days, seek medicaadvice.

Do not exceed the recommendeodaily dosage without doctor's

instruction.

Consult a doctor immediately if bleeding occurs.

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

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 consult a doctor if symptoms persist or worsen, including redness, irritation. swelling, 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)

Some people may be allergic tothe ingredients. Discontinue use andconsult a doctor if symptoms persistor worsen,including rednessirritation,swelling,or pain.

When Using

If symptoms worsen or do not improve within 7 days, seek medicaladvice.Do not exceed the recommended daily dosage without doctor'sinstruction.Consult a doctor immediately if bleeding occurs.

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

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

Active Ingredient

Lidocaine 5%

Other Information (Other information)

Keep away from direct sunlight orheat.

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

This package is child-resistant.Keep out of reach of children. In case of accidental overdose oringestion, call a doctor or poisoncontrol center immediately. Do not use this product if the sealis broken or missing.

Inactive Ingredients (Inactive ingredients)

Vitamin E Allantoin, Mineral Oil.Dimethicone,MethylparabenPropylparaben, Petrolatum, IPBCDiazolidinyl Urea, Glycerin,Cetostearyl Alcohol, IsopropylMyristate, Propylene Glycol,Ammonium,Methacrylate, PurifiedWater, Laurocapram, Steareth-2.Steareth-21 Rose Oil

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

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


Advanced Ingredient Data


Raw Label Data

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