SPL v1
SPL
SPL Set ID b872ab82-b823-4444-925b-846c39467a06
Route
TOPICAL
Published
Effective Date 2024-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Water Propylene Glycol Glycerin Carbomer Homopolymer, Unspecified Type Edetate Disodium Anhydrous Hydroxyacetophenone 1,2-hexanediol Tocopherol Mentha Arvensis Leaf Chrysanthellum Indicum Top Purslane Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-08

Description

Lidocaine 5%

Purpose

local anesthetic

Storage and Handling

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


Medication Information

Purpose

local anesthetic

Storage and Handling

Store between 15-30℃(59-86 F ).

-Avoid freezing and excessive heat above 40℃(104 F ).

Description

Lidocaine 5%

Use

For temporary relief of local discomfort, itching, pain,soreness or burning of the skin

Section 50565-1

Keep out of reach of children. 

Do Not Use

When Using

1.Conduct a patch test before use to check for allergic reactions or skin sensitivities.

2.Avoid contact with eyes.

3.lf this happens, rinse thoroughly with water.

Safe Notice 

1. Avoid prolonged exposure to sunlight or UV rays after applying the cream.

2. Use caution when applying the cream near or around sensitive areas, such asthe face or genitals.

3. Avoid contact with eyes, mouth, and other sensitive areas.4. Not recommended for use on broken or irritated skin.

Usage Directions

1. Clean the tattooed area with mild soap and water and dry.

2.Apply a layer of tattoo numbing cream evenly to the desired area.

3. To enhance the anesthetic effect, cover the tattooed area with plastic wrapor cling film for about 30 minutes.

4. Remove the cling film and wipe off any excess numbing cream with a cleantissue.

Active Ingredient(s)

Lidocaine 5%

Inactive Ingredients

Water, Propylene Glycol, Glycerin, Carbomer Homopolymer, Unspecified Type,Edetate Disodium Anhydrous, Hydroxyacetophenone,1,2-Hexanediol, Tocopherol,Mentha arvensis Leaf, Chrysanthemum Indicum Top, Purslane, Polyoxyl 40Hydrogenated Castor Oil.

Stop Use and Consult A Doctor

If irritation, redness, or swelling persists or increases.

-lf you experience any unexpected or severe side effects.

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

Package Label Principal Display Panel


Structured Label Content

Use

For temporary relief of local discomfort, itching, pain,soreness or burning of the skin

Section 50565-1 (50565-1)

Keep out of reach of children. 

Purpose

local anesthetic

Do Not Use (Do not use)

When Using (When using)

1.Conduct a patch test before use to check for allergic reactions or skin sensitivities.

2.Avoid contact with eyes.

3.lf this happens, rinse thoroughly with water.

Safe Notice 

1. Avoid prolonged exposure to sunlight or UV rays after applying the cream.

2. Use caution when applying the cream near or around sensitive areas, such asthe face or genitals.

3. Avoid contact with eyes, mouth, and other sensitive areas.4. Not recommended for use on broken or irritated skin.

Usage Directions (USAGE DIRECTIONS)

1. Clean the tattooed area with mild soap and water and dry.

2.Apply a layer of tattoo numbing cream evenly to the desired area.

3. To enhance the anesthetic effect, cover the tattooed area with plastic wrapor cling film for about 30 minutes.

4. Remove the cling film and wipe off any excess numbing cream with a cleantissue.

Active Ingredient(s)

Lidocaine 5%

Inactive Ingredients (Inactive ingredients)

Water, Propylene Glycol, Glycerin, Carbomer Homopolymer, Unspecified Type,Edetate Disodium Anhydrous, Hydroxyacetophenone,1,2-Hexanediol, Tocopherol,Mentha arvensis Leaf, Chrysanthemum Indicum Top, Purslane, Polyoxyl 40Hydrogenated Castor Oil.

Storage and Handling (Storage and handling)

Store between 15-30℃(59-86 F ).

-Avoid freezing and excessive heat above 40℃(104 F ).

Stop Use and Consult A Doctor (Stop Use and Consult a Doctor)

If irritation, redness, or swelling persists or increases.

-lf you experience any unexpected or severe side effects.

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

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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