SPL v1
SPL
SPL Set ID 334b31d9-85f8-ac41-e063-6394a90a4fb1
Route
TOPICAL
Published
Effective Date 2025-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (3 g)
Inactive Ingredients
Menthol Purslane Chrysanthellum Indicum Top Tocopherol Aqua Lecithin, Soybean Glycerin Aloe

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-21

Description

Lidocaine:5%


Medication Information

Warnings and Precautions



WARNING

For external use only.lf an allergic reaction occursdiscontinue use and consult adoctor.

lf pregnant or breastfeeding,consult a healthcare professionalbefore use.

Do not use if the seal is brokenor missing

Indications and Usage

USESTemporarily relieves localdiscomfort, itching, pain, soreness,or burning on the skin surface.

Dosage and Administration

to an appropriate extent for product

Description

Lidocaine:5%

Section 50565-1

KEEP OUT OF REACHOF CHIDREN

If swallowed, go to the nearesthospital and seek immediatemedical help.

Section 50566-9

Do not use if the seal is brokenor missing

Section 50567-7



WHEN USING THIS PRODUCTDo not exceed the recommended daily dosage unless directed bya doctor.

In case of accidental ingestionor overdose, seek medical helpimmediately or contact a PoisonControl Center.

Section 50570-1

lf pregnant or breastfeeding,consult a healthcare professionalbefore use.

Section 51727-6

Menthol

Chrysanthellum indicum extract

Portulaca oleracea extract

Vitamin E

Aloe Vera

Glycerin

Lecithin

Purified Water

Section 51945-4

Section 55105-1

Local Anesthetic

Section 55106-9

Lidocaine:5%


Structured Label Content

Indications and Usage (34067-9)

USESTemporarily relieves localdiscomfort, itching, pain, soreness,or burning on the skin surface.

Dosage and Administration (34068-7)

to an appropriate extent for product

Warnings and Precautions (34071-1)



WARNING

For external use only.lf an allergic reaction occursdiscontinue use and consult adoctor.

lf pregnant or breastfeeding,consult a healthcare professionalbefore use.

Do not use if the seal is brokenor missing

Section 50565-1 (50565-1)

KEEP OUT OF REACHOF CHIDREN

If swallowed, go to the nearesthospital and seek immediatemedical help.

Section 50566-9 (50566-9)

Do not use if the seal is brokenor missing

Section 50567-7 (50567-7)



WHEN USING THIS PRODUCTDo not exceed the recommended daily dosage unless directed bya doctor.

In case of accidental ingestionor overdose, seek medical helpimmediately or contact a PoisonControl Center.

Section 50570-1 (50570-1)

lf pregnant or breastfeeding,consult a healthcare professionalbefore use.

Section 51727-6 (51727-6)

Menthol

Chrysanthellum indicum extract

Portulaca oleracea extract

Vitamin E

Aloe Vera

Glycerin

Lecithin

Purified Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Local Anesthetic

Section 55106-9 (55106-9)

Lidocaine:5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)