SPL v1
SPL
SPL Set ID 322daa32-a74e-1fee-e063-6294a90a37aa
Route
CUTANEOUS
Published
Effective Date 2025-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (100 mg)
Inactive Ingredients
Carbomer Water Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-07
Description

For external use only.Avoid contact with eyes.Patch test before full use.Patch test before full use.

Medication Information

Warnings and Precautions

For external use only.Avoid contact with eyes.Patch test before full use.Patch test before full use.

Indications and Usage

Store in a cool place at 59-68°F, away from direct sunlight.

Dosage and Administration

Apply 1-3 times a week

Description

For external use only.Avoid contact with eyes.Patch test before full use.Patch test before full use.

Section 50566-9

Discontinue use if irritation occurs.

Section 50567-7

Wash the area with soap. Apply a 2 mm-thick layer, rub it in for 1-2 minutes, and

cover with a waterproof film approximately 30-50 minutes before your procedure.

Section 51727-6

Benzyl Alcohol, Carbomer, Lecithin,Mentha Arvensis Leaf Extract,chrysanthemum indicum Extract, Portulaca Oleracea Extract,Propylene Glycol, Tocopheryl Acetate, Water

Section 51945-4

Section 55105-1

For numbing a localized topical area to ease painduring tattooing and cosmetic procedures.

Section 55106-9

4% LIDOCAINE

Structured Label Content

Indications and Usage (34067-9)

Store in a cool place at 59-68°F, away from direct sunlight.

Dosage and Administration (34068-7)

Apply 1-3 times a week

Warnings and Precautions (34071-1)

For external use only.Avoid contact with eyes.Patch test before full use.Patch test before full use.

Section 50566-9 (50566-9)

Discontinue use if irritation occurs.

Section 50567-7 (50567-7)

Wash the area with soap. Apply a 2 mm-thick layer, rub it in for 1-2 minutes, and

cover with a waterproof film approximately 30-50 minutes before your procedure.

Section 51727-6 (51727-6)

Benzyl Alcohol, Carbomer, Lecithin,Mentha Arvensis Leaf Extract,chrysanthemum indicum Extract, Portulaca Oleracea Extract,Propylene Glycol, Tocopheryl Acetate, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For numbing a localized topical area to ease painduring tattooing and cosmetic procedures.

Section 55106-9 (55106-9)

4% LIDOCAINE

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:52.116506 · Updated: 2026-03-14T23:08:14.770901