SPL v2
SPL
SPL Set ID 05eea032-da99-5d18-e063-6394a90a9fcc
Route
TOPICAL
Published
Effective Date 2023-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Propylene Glycol Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Aloe Vera Leaf Water Lecithin, Soybean .alpha.-tocopherol Acetate Menthol, Unspecified Form Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-22

Description

Lidocaine 5%

Purpose

local anesthetic

Storage and Handling

*Always keep tihgtly closed *Store at temperatures between 59°F-86°F(15°C-30°C) *Protectfrom freezing


Medication Information

Purpose

local anesthetic

Storage and Handling

*Always keep tihgtly closed

*Store at temperatures between 59°F-86°F(15°C-30°C)

*Protectfrom freezing

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. 

Section 50566-9

lf allergy occurs such as redness,irritation,swelling,pain or other symptoms become severe Stop use and get to a doctor.If symptoms persist for more than 7days or subside but occur again within3 days,stop use and consult aphysician.

Section 50567-7

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

Warnings

For external use only.

Directions

1.Wash and exfoliate the area to be treated.

2.Dry the area completely.

3.Apply this numbing cream(2mm thick) to the area and rub in thoroughly

4.Cover with cling film.

5.leave the cream and wrap in place for 60-90 minutes before procedure.

6.After the wrapping time,remove thecling film and wipe the cream away

Do Not Use

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

Active Ingredient(s)

Lidocaine 5%

Inactive Ingredients

Lecithin(Soybean),Propylene Glycol,Tocopheryl Acctate,Aloe Vera,Water,Carbomer,Menthol,Triethanolamine

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. 

Section 50566-9 (50566-9)

lf allergy occurs such as redness,irritation,swelling,pain or other symptoms become severe Stop use and get to a doctor.If symptoms persist for more than 7days or subside but occur again within3 days,stop use and consult aphysician.

Section 50567-7 (50567-7)

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

Purpose

local anesthetic

Warnings

For external use only.

Directions

1.Wash and exfoliate the area to be treated.

2.Dry the area completely.

3.Apply this numbing cream(2mm thick) to the area and rub in thoroughly

4.Cover with cling film.

5.leave the cream and wrap in place for 60-90 minutes before procedure.

6.After the wrapping time,remove thecling film and wipe the cream away

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)

Lecithin(Soybean),Propylene Glycol,Tocopheryl Acctate,Aloe Vera,Water,Carbomer,Menthol,Triethanolamine

Storage and Handling (Storage and handling)

*Always keep tihgtly closed

*Store at temperatures between 59°F-86°F(15°C-30°C)

*Protectfrom freezing

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


Advanced Ingredient Data


Raw Label Data

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