SPL v1
SPL
SPL Set ID 2f905d76-ef9c-c844-e063-6394a90a4dc9
Route
CUTANEOUS
Published
Effective Date 2025-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (100 mg)
Inactive Ingredients
Glycerin Carbomer Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-06

Description

For external use only.Stop use and consulta doctor if an allergicreaction occurs. Keep out of reach of children. Keep away from direct sunlight and store at a temperature between 15 to 30'C(59 to 86'F).


Medication Information

Warnings and Precautions

For external use only.Stop use and consulta doctor if an allergicreaction occurs.

Keep out of reach of children. Keep away from direct sunlight and store at a temperature between 15 to 30'C(59 to 86'F).

Indications and Usage

Apply a 2mm thick layer of cream, rub it in, and cover it with a waterproof film.Leave on for approximately 90 minutes before your procedure for maximum numbing effect.

Dosage and Administration

Apply 1-3 times a week

Description

For external use only.Stop use and consulta doctor if an allergicreaction occurs. Keep out of reach of children. Keep away from direct sunlight and store at a temperature between 15 to 30'C(59 to 86'F).

Section 50566-9

Discontinueuse if signs of irritation or rash occur

Section 50567-7

Wash the area with soap and water.

Section 51727-6

Water, Aleo vera

extract, Vitamin E,Propylene Glycol,Carbomer, Glycerin,Disodium Edta.

Hydroxyacetophenone,

1.2-Hexanediol, Mentha Arvensis Leaf Extract,

Chrysanthellum

Indicum Extract,

Portulaca Oleracea Extract.

Section 51945-4

Section 55105-1

Best for painless tattoo and cosmetic procedures

Section 55106-9

5% Lidocaine


Structured Label Content

Indications and Usage (34067-9)

Apply a 2mm thick layer of cream, rub it in, and cover it with a waterproof film.Leave on for approximately 90 minutes before your procedure for maximum numbing effect.

Dosage and Administration (34068-7)

Apply 1-3 times a week

Warnings and Precautions (34071-1)

For external use only.Stop use and consulta doctor if an allergicreaction occurs.

Keep out of reach of children. Keep away from direct sunlight and store at a temperature between 15 to 30'C(59 to 86'F).

Section 50566-9 (50566-9)

Discontinueuse if signs of irritation or rash occur

Section 50567-7 (50567-7)

Wash the area with soap and water.

Section 51727-6 (51727-6)

Water, Aleo vera

extract, Vitamin E,Propylene Glycol,Carbomer, Glycerin,Disodium Edta.

Hydroxyacetophenone,

1.2-Hexanediol, Mentha Arvensis Leaf Extract,

Chrysanthellum

Indicum Extract,

Portulaca Oleracea Extract.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Best for painless tattoo and cosmetic procedures

Section 55106-9 (55106-9)

5% Lidocaine


Advanced Ingredient Data


Raw Label Data

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