1de1169c-e6dd-486f-e063-6394a90a3b59

Set ID
1de1169c-e6dd-486f-e063-6394a90a3b59
Manufacturer
Medhome Pharma Inc
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:23:07

Key Label Information

Active Ingredients And Purpose

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses

Use

For temporary relief of local discomfort, itching, pain, soreness, or burning related to the tattoo process

Warnings

Warnings

For external use only.

Do not use

Do not exceed the recommended daily dosage unless directed by a doctor

Directions And Dosage

Directions

Before applying the numbing cream, thoroughly wash your hands and wear disposable tattoo gloves. Clean the area of the body receivina the tattoo,Dry completely. Apply a generous amount of numbing cream to the cleaned area and rub it inthoroughly in a circlar motion for30 to 60 seconds,Then. cover with plastic wrap. Leave the cream and wrap in place for 30 to 45 minutes,Wipe away the cream and thoroughly clean the area to prepare for a pain-free tattoo.

Other Label Information

Inactive ingredients

Water,Carbomer934, propylene Glycol,soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.

Package

Products

NDC Codes

Ingredients

NameUNIIKind
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER 934Z135WT9208IACT
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
SOYBEAN LECITHIN1DI56QDM62IACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Complete SPL Sections

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Use

INDICATIONS & USAGE SECTION

For temporary relief of local discomfort, itching, pain, soreness, or burning related to the tattoo process

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not exceed the recommended daily dosage unless directed by a doctor

Stop Use

OTC - STOP USE SECTION

Do not exceed the recommended daily dosage unless directed by a doctor. Avoid contact with eyes. lf this happens, rinse thoroughly with water. lf symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician. Stop use and seek medical attention if signs of an allergy occur, such as redness,iritation, sweling, pain, or other severe symptoms. fsymptoms do not subside completely within 7 days, seek medica help.

Ask Doctor

OTC - ASK DOCTOR/PHARMACIST SECTION

Stop use and sek meditcal attention if signs of an alerqy occur,such as rednes,irtation,sweling, pain, or other severe symptoms.If symptoms do not subside completely within 7 days, seek medical help.

Directions

DOSAGE & ADMINISTRATION SECTION

Before applying the numbing cream, thoroughly wash your hands and wear disposable tattoo gloves. Clean the area of the body receivina the tattoo,Dry completely. Apply a generous amount of numbing cream to the cleaned area and rub it inthoroughly in a circlar motion for30 to 60 seconds,Then. cover with plastic wrap. Leave the cream and wrap in place for 30 to 45 minutes,Wipe away the cream and thoroughly clean the area to prepare for a pain-free tattoo.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Other information

OTHER SAFETY INFORMATION

Store between 15-30℃(59-86F). Avoid freezing and excessive heat above 40 ℃(104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water,Carbomer934, propylene Glycol,soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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dailymed/1de1169c-e6dd-486f-e063-6394a90a3b59/45f8c3ac-697c-d3de-e063-6394a90aa1bc.xml
XML SHA-256
8cbf303c26919b393af11c147ae8165f737c1161a80baac8606d532054121a21
XML bytes
20308

Legacy File Index

FolderFileDate
otc45f8c3ac-697c-d3de-e063-6394a90aa1bc.xml2025-12-16
otcLidocaine.jpg2025-12-16
otc1.jpg2024-08-06
otc1de1169c-e6de-486f-e063-6394a90a3b59.xml2024-08-06