Initial Drug Listing - 5% Lidocaine Numbing Cream

Drug Facts

Composition & Product

Active Ingredients

Menthol (7 mg) Lidocaine (50 mg)

Inactive Ingredients

Water Alpha-tocopherol Acetate Carbomer 934 Benzyl Alcohol Propylene Glycol Emu Oil Arnica Montana Flower Lecithin, Soybean

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-06-12

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For temporary relief local discomfort, itching, pain, soreness, or burning inthe perianal area associated with anorectal disorders and anorectal inflammation.

Dosage and Administration

For adults: Cleanse the affected area with mild soap and warm water, and rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying the product.
Apply up to 4 times a day.
For children under 12 years of age: Consult a doctor.

Description

Lidocaine 5% Menthol 0.7%

Section 50565-1

Keep out of reach of children

Avoid contact with eyes.

In case of accidental ingestion, seek medical attention immediately.

Section 50566-9

Stop using and ask a doctor

If discomfort persists for 7 days.
The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.

Section 50567-7

Only take the recommended daily dosage unless otherwise instructed by a doctor.
Some individuals may experience allergic reactions to the ingredientscontained in this product.
Never put it into the rectum by using the finger or any medical device.

Section 50570-1

Do not use this product if

Pregnant or breastfeeding, ask a health professional before use.
If there is any allergic reaction to this product.
In case of accidental overdose, get medical help, or contact the poison control center immediately.

Section 51727-6

Water, Arnica, Emu Oil, Lecithin(Soybean), Propylene Glycol,Tocopheryl Acetate, Carbomer 934, Benzyl Alcohol.

Section 51945-4

Section 55105-1

Local Anesthetic

Section 55106-9

Lidocaine 5%

Menthol 0.7%

Section 60561-8

Keep away from direct sunlight or heat.
Store at room temperature 59~-86°F(15°-30°C).

Structured Label Content

Indications and Usage (34067-9)

For temporary relief local discomfort, itching, pain, soreness, or burning inthe perianal area associated with anorectal disorders and anorectal inflammation.

Dosage and Administration (34068-7)

For adults: Cleanse the affected area with mild soap and warm water, and rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying the product.
Apply up to 4 times a day.
For children under 12 years of age: Consult a doctor.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children

Avoid contact with eyes.

In case of accidental ingestion, seek medical attention immediately.

Section 50566-9 (50566-9)

Stop using and ask a doctor

If discomfort persists for 7 days.
The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.

Section 50567-7 (50567-7)

Only take the recommended daily dosage unless otherwise instructed by a doctor.
Some individuals may experience allergic reactions to the ingredientscontained in this product.
Never put it into the rectum by using the finger or any medical device.

Section 50570-1 (50570-1)

Do not use this product if

Pregnant or breastfeeding, ask a health professional before use.
If there is any allergic reaction to this product.
In case of accidental overdose, get medical help, or contact the poison control center immediately.

Section 51727-6 (51727-6)

Water, Arnica, Emu Oil, Lecithin(Soybean), Propylene Glycol,Tocopheryl Acetate, Carbomer 934, Benzyl Alcohol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Local Anesthetic

Section 55106-9 (55106-9)

Lidocaine 5%

Menthol 0.7%

Section 60561-8 (60561-8)

Keep away from direct sunlight or heat.
Store at room temperature 59~-86°F(15°-30°C).

Advanced Ingredient Data

[{"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "7", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE", "unii": "98PI200987", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EMU OIL", "unii": "344821WD61", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARNICA MONTANA FLOWER", "unii": "OZ0E5Y15PZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For temporary relief local discomfort, itching, pain, soreness, or burning inthe perianal area associated with anorectal disorders and anorectal inflammation.", "34068-7": "For adults: Cleanse the affected area with mild soap and warm water, and rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying the product. Apply up to 4 times a day. For children under 12 years of age: Consult a doctor.", "34071-1": "For external use only", "50565-1": "Keep out of reach of children Avoid contact with eyes. In case of accidental ingestion, seek medical attention immediately.", "50566-9": "Stop using and ask a doctor If discomfort persists for 7 days. The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.", "50567-7": "Only take the recommended daily dosage unless otherwise instructed by a doctor. Some individuals may experience allergic reactions to the ingredientscontained in this product. Never put it into the rectum by using the finger or any medical device.", "50570-1": "Do not use this product if Pregnant or breastfeeding, ask a health professional before use. If there is any allergic reaction to this product. In case of accidental overdose, get medical help, or contact the poison control center immediately.", "51727-6": "Water, Arnica, Emu Oil, Lecithin(Soybean), Propylene Glycol,Tocopheryl Acetate, Carbomer 934, Benzyl Alcohol.", "55105-1": "Local Anesthetic Local Anesthetic", "55106-9": "Lidocaine 5% Menthol 0.7%", "60561-8": "Keep away from direct sunlight or heat. Store at room temperature 59~-86°F(15°-30°C)."}