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SPL v1

SPL

SPL Set ID 2f80abc0-49d8-968d-e063-6294a90a555b

Route

CUTANEOUS

Published

Effective Date 2025-03-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Lidocaine (100 mg)

Inactive Ingredients

Water Benzyl Alcohol Lecithin, Soybean Carbomer 934

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-03-04

Description

Stop use and consulta doctor if an allergicreaction occurs. Keep out of reach of children.

Medication Information

Warnings and Precautions

Stop use and consulta doctor if an allergicreaction occurs.

Keep out of reach of children.

Indications and Usage

Apply a 2mm thick layer of cream, rub it in, and cover it with a waterproof film.Leave on for approximately 90 minutes before your procedure for maximum numbing effect.

Dosage and Administration

Apply 1-3 times a week

Description

Stop use and consulta doctor if an allergicreaction occurs. Keep out of reach of children.

Section 50566-9

Discontinueuse if signs of irritation or rash occur

Section 50567-7

Wash the area with soap and water.

Section 51727-6

Benzyl Alcohol, Carbomer 934, Lecithin(Soybean), Propylene Glycol, Tocopheryl Acetate, Water

Section 51945-4

Section 55105-1

Used for numbing local area prior to tattooing

Section 55106-9

5% Lidocaine

Structured Label Content

Indications and Usage (34067-9)

Apply a 2mm thick layer of cream, rub it in, and cover it with a waterproof film.Leave on for approximately 90 minutes before your procedure for maximum numbing effect.

Dosage and Administration (34068-7)

Apply 1-3 times a week

Warnings and Precautions (34071-1)

Stop use and consulta doctor if an allergicreaction occurs.

Keep out of reach of children.

Section 50566-9 (50566-9)

Discontinueuse if signs of irritation or rash occur

Section 50567-7 (50567-7)

Wash the area with soap and water.

Section 51727-6 (51727-6)

Benzyl Alcohol, Carbomer 934, Lecithin(Soybean), Propylene Glycol, Tocopheryl Acetate, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Used for numbing local area prior to tattooing

Section 55106-9 (55106-9)

5% Lidocaine

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE", "unii": "98PI200987", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Apply a 2mm thick layer of cream, rub it in, and cover it with a waterproof film.Leave on for approximately 90 minutes before your procedure for maximum numbing effect.", "34068-7": "Apply 1-3 times a week", "34071-1": "Stop use and consulta doctor if an allergicreaction occurs. Keep out of reach of children.", "50566-9": "Discontinueuse if signs of irritation or rash occur", "50567-7": "Wash the area with soap and water.", "51727-6": "Benzyl Alcohol, Carbomer 934, Lecithin(Soybean), Propylene Glycol, Tocopheryl Acetate, Water", "55105-1": "Used for numbing local area prior to tattooing", "55106-9": "5% Lidocaine"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:40.038693 · Updated: 2026-03-14T23:07:49.806657