334b31d9-85f8-ac41-e063-6394a90a4fb1

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

Active Ingredient

Lidocaine:5%

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


Structured Label Content

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

Active Ingredient (55106-9)

Lidocaine:5%

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)