SPL v2
SPL
SPL Set ID 3026c8e2-d8f4-9f9f-e063-6394a90a32a0
Route
TOPICAL
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Benzyl Alcohol Edetate Disodium Aloe Barbadensis Leaf Tert-butyl Alcohol Kus-121 Dihydrate Glyceryl Laurate Carbomer 940 Glycerin Butyrospermum Parkii (shea) Butter Simmondsia Chinensis (jojoba) Seed Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

Description

Active Ingredient: Lidocaine 5% Local Anesthetic

Purpose

Efficacy: numb the skin, suitable for tattoos, micro-plastic surgery, permanent makeup.


Medication Information

Purpose

Efficacy: numb the skin, suitable for tattoos, micro-plastic surgery, permanent makeup.

Description

Active Ingredient: Lidocaine 5% Local Anesthetic

Dosage

Apply 2 mm to 3 mm of anesthetic cream to the surgical area

Warning

Storage: Please store in a dry, cool place and out of reach of children

Indication

Usage: external use on skin

Stop to Use

Note: if You feel uncomfortable during use, please stop usina it immediately and seek medical treatment if necessary

When to Use

Step instructions:

1. Clean the skin of the surgical area

3.Cover with plastic wrap and wait 45-60 minutes

2. Apply 2 mm to 3 mm of anesthetic cream to the surgical area

4. Wipe off the residue, rinse well, and then start tattooing.

85342 001 01

Active Ingredient

Active Ingredient: Lidocaine 5%

Local Anesthetic

Inactive Ingredients

Inactive Ingredients: Aloe Barbadensis Leaf Extract, Alpha Bisabolol, Benzyl Alcohol, Carbomer 940, EDTA Disodium, Dihydrate

Glycerin, Glyceryl Monolaurate,Specially Denatured Ethy! Alcohol Formula 40 B 200 Proof, Butirospermum Parki (Shea) Butter,Simmondsia Chinensis (Jojoba)Seed Oil, Water, Purified

Keep Out of Children

Please store in a dry, cool place and out of reach of children


Structured Label Content

Dosage

Apply 2 mm to 3 mm of anesthetic cream to the surgical area

Purpose (purpose)

Efficacy: numb the skin, suitable for tattoos, micro-plastic surgery, permanent makeup.

Warning (warning)

Storage: Please store in a dry, cool place and out of reach of children

Indication

Usage: external use on skin

Stop to Use (stop to use)

Note: if You feel uncomfortable during use, please stop usina it immediately and seek medical treatment if necessary

When to Use (when to use)

Step instructions:

1. Clean the skin of the surgical area

3.Cover with plastic wrap and wait 45-60 minutes

2. Apply 2 mm to 3 mm of anesthetic cream to the surgical area

4. Wipe off the residue, rinse well, and then start tattooing.

85342 001 01 (85342-001-01)

Active Ingredient (active ingredient)

Active Ingredient: Lidocaine 5%

Local Anesthetic

Inactive Ingredients

Inactive Ingredients: Aloe Barbadensis Leaf Extract, Alpha Bisabolol, Benzyl Alcohol, Carbomer 940, EDTA Disodium, Dihydrate

Glycerin, Glyceryl Monolaurate,Specially Denatured Ethy! Alcohol Formula 40 B 200 Proof, Butirospermum Parki (Shea) Butter,Simmondsia Chinensis (Jojoba)Seed Oil, Water, Purified

Keep Out of Children (keep out of children)

Please store in a dry, cool place and out of reach of children


Advanced Ingredient Data


Raw Label Data

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