83391-009

83391-009
SPL v3
SPL
SPL Set ID 358c2632-3b90-1c54-e063-6294a90ad461
Route
TOPICAL
Published
Effective Date 2025-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Alcohol Lavender Oil Polysorbate 80 Aloe Vera Leaf Oil Trolamine Glycerin Ethylparaben Racementhol Carbomer 940

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-20

Description

Drug Facts


Medication Information

Warnings and Precautions

Please read all directions and warnings as follows and use only as directed. For external use only.

Keep out of reach of children and pets. If ingested, get medical help right away.

Indications and Usage

For the temporay relief of pain

Dosage and Administration

Apply a thin layer to the affected area every 6 to 8 hours.

Children under 12 years of age:do not use, consult a doctor.

Use no more than three times in a day.

Wash hands after use.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Store it in a dry place at room temperature between 20-25°C (68-77°F) and away from direct sunlight.

Section 50565-1

Keep out of reach of children and pets. If ingested, get medical help right away.

Section 50566-9

Stop use and ask a doctor

if symptoms persist for more than / days or clear up and occur again within a few davs.

if you experience any signs of deterioration or skin iniurv. such as redness, irritation, sweling, or bistering.

Section 50570-1

Do not use

if you're allergic to the listed ingredients.

if the package arrives damaged or opened.

if you are pregnant or breast-feeding.

at the same time as other topical analgesics.

on eyes, mucous membranes, cuts, wounds damaged, broken, swolen. or irritated skin.

In large quantities. particularly over raw surfaces or blistered area

Section 51727-6

Aloe oil, Carbomer 940, Ethyl Alcohol, Ethyl Paraben, Glycerin, Lavander oil,

Menthol, Polysorbate 80, Trolamine, Water

Section 51945-4

Section 55105-1

Topical Analgestic

Section 55106-9

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

For the temporay relief of pain

Dosage and Administration (34068-7)

Apply a thin layer to the affected area every 6 to 8 hours.

Children under 12 years of age:do not use, consult a doctor.

Use no more than three times in a day.

Wash hands after use.

Warnings and Precautions (34071-1)

Please read all directions and warnings as follows and use only as directed. For external use only.

Keep out of reach of children and pets. If ingested, get medical help right away.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Store it in a dry place at room temperature between 20-25°C (68-77°F) and away from direct sunlight.

Section 50565-1 (50565-1)

Keep out of reach of children and pets. If ingested, get medical help right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor

if symptoms persist for more than / days or clear up and occur again within a few davs.

if you experience any signs of deterioration or skin iniurv. such as redness, irritation, sweling, or bistering.

Section 50570-1 (50570-1)

Do not use

if you're allergic to the listed ingredients.

if the package arrives damaged or opened.

if you are pregnant or breast-feeding.

at the same time as other topical analgesics.

on eyes, mucous membranes, cuts, wounds damaged, broken, swolen. or irritated skin.

In large quantities. particularly over raw surfaces or blistered area

Section 51727-6 (51727-6)

Aloe oil, Carbomer 940, Ethyl Alcohol, Ethyl Paraben, Glycerin, Lavander oil,

Menthol, Polysorbate 80, Trolamine, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgestic

Section 55106-9 (55106-9)

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)