SPL v1
SPL
SPL Set ID 39773cab-12df-4520-e063-6294a90abc5b
Route
CUTANEOUS
Published
Effective Date 2025-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g) Epinephrine (1 g)
Inactive Ingredients
Propylene Glycol Carbomer Procaine Triethanolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-09

Description

Lidocaine 5%, Epinephrine 1%


Medication Information

Warnings and Precautions

n/a

Indications and Usage

As directed by the physician.

Usable RangeMcro Needle Pain Tattooing Body Piercing,Laser Tattoo Removal, Laser Hair Removal, Waxing,Permanent Cosmetics.

Dosage and Administration

Usage

1. Rotate the nozzle with the top of the cap. Resealed after use.

2.Wash the skin with soap and warm water making sure It's clean and free of bacteria.

3.Put the anesthetic evenly on the skin(1/8 inch or2-3mm thick), and cover the skin with a plastic wrap for 50-60 minutes toachieve 6-10 hours of numbness.

4.Before starting the operation,Remove the cream and let the skin breathe for 5-10minutes before proceeding with the work.When using this product, please control the room temperatue at 28C ~30C,so that the skin can absorb the cream quicker.

Description

Lidocaine 5%, Epinephrine 1%

Section 44425-7

Storage

Store above Zero and Below30°℃.

Protect from Light.

Do not freeze.

Section 50565-1

Keep out of reach for children.

Section 50566-9

Stop using and ask your doctor if you have any irritation or rash. These may be signs of a serious illness.

Please stay away from children.If you swallow, seek medical attention immediately

Section 50567-7

Keep away from your eyes when using this product. If in contact with eyes, wash eyes thoroughly with water.

Section 50570-1

Do not use:Under 18 must be accompanied by an adult

Section 51727-6

Prilccaine, Carbomer, Propylene Glycol, Triethanolamine

Section 51945-4

Section 55105-1

Topical pain relief and wound repair

Section 55106-9

Lidocaine 5%, Epinephrine 1%


Structured Label Content

Indications and Usage (34067-9)

As directed by the physician.

Usable RangeMcro Needle Pain Tattooing Body Piercing,Laser Tattoo Removal, Laser Hair Removal, Waxing,Permanent Cosmetics.

Dosage and Administration (34068-7)

Usage

1. Rotate the nozzle with the top of the cap. Resealed after use.

2.Wash the skin with soap and warm water making sure It's clean and free of bacteria.

3.Put the anesthetic evenly on the skin(1/8 inch or2-3mm thick), and cover the skin with a plastic wrap for 50-60 minutes toachieve 6-10 hours of numbness.

4.Before starting the operation,Remove the cream and let the skin breathe for 5-10minutes before proceeding with the work.When using this product, please control the room temperatue at 28C ~30C,so that the skin can absorb the cream quicker.

Warnings and Precautions (34071-1)

n/a

Section 44425-7 (44425-7)

Storage

Store above Zero and Below30°℃.

Protect from Light.

Do not freeze.

Section 50565-1 (50565-1)

Keep out of reach for children.

Section 50566-9 (50566-9)

Stop using and ask your doctor if you have any irritation or rash. These may be signs of a serious illness.

Please stay away from children.If you swallow, seek medical attention immediately

Section 50567-7 (50567-7)

Keep away from your eyes when using this product. If in contact with eyes, wash eyes thoroughly with water.

Section 50570-1 (50570-1)

Do not use:Under 18 must be accompanied by an adult

Section 51727-6 (51727-6)

Prilccaine, Carbomer, Propylene Glycol, Triethanolamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical pain relief and wound repair

Section 55106-9 (55106-9)

Lidocaine 5%, Epinephrine 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)