SPL v1
SPL
SPL Set ID a7c90623-5baf-49ff-b749-033dfffcd1c2
Route
TOPICAL
Published
Effective Date 2023-08-07
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 FINAL Active Since 2023-08-07

Description

Lidocaine 5%

Purpose

For temporary relief of local discomfort, itching,pain, soreness or burning related to the tattooprocess.

Storage and Handling

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


Medication Information

Purpose

For temporary relief of local discomfort, itching,pain, soreness or burning related to the tattooprocess.

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

Lidocaine 5%

Use

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

Section 50565-1

Keep out of reach of children. 

Section 50566-9

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 get to a doctor if allergy occurs such as redness, irritation, swelling, pain or other symptoms become severe or does not subside completely within 7 days.

Section 50567-7

Avoid contact with eyes. If this happens, rinse thoroughly with water.

Warnings

For external use only.

Directions

1. Clean the specific area, thendry.

2.Apply cream to the area to betattooed with a thick coat (near 2mm) . Wrap the applied area tightly with plasticwrap and waitfor 45~65 minutes.

3.Tear off the plastic wrap, wipeoff cream, wait for 25 minutesmore to start your tattoo work.

Do Not Use

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

Active Ingredient(s)

Lidocaine 5%

Inactive Ingredients

WATER,PROPYLENE GLYCOL,GLYCERIN,CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE,EDETATE DISODIUM ANHYDROUS,

HYDROXYACETOPHENONE,1,2-HEXANEDIOL,Tocopherol,MENTHAARVENSIS LEAF,CHRYSANTHELLUM INDICUM TOP, PURSLANE,POLYOXYL40 HYDROGENATED CASTOR OIL

Package Label Principal Display Panel


Structured Label Content

Use

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

Section 50565-1 (50565-1)

Keep out of reach of children. 

Section 50566-9 (50566-9)

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 get to a doctor if allergy occurs such as redness, irritation, swelling, pain or other symptoms become severe or does not subside completely within 7 days.

Section 50567-7 (50567-7)

Avoid contact with eyes. If this happens, rinse thoroughly with water.

Purpose

For temporary relief of local discomfort, itching,pain, soreness or burning related to the tattooprocess.

Warnings

For external use only.

Directions

1. Clean the specific area, thendry.

2.Apply cream to the area to betattooed with a thick coat (near 2mm) . Wrap the applied area tightly with plasticwrap and waitfor 45~65 minutes.

3.Tear off the plastic wrap, wipeoff cream, wait for 25 minutesmore to start your tattoo work.

Do Not Use (Do not use)

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

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,MENTHAARVENSIS LEAF,CHRYSANTHELLUM INDICUM TOP, PURSLANE,POLYOXYL40 HYDROGENATED CASTOR OIL

Storage and Handling (Storage and handling)
  • Store between 15-30℃(59-86F).Avoid freezing and excessive heat above 40℃(104F).
Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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