SPL v4
SPL
SPL Set ID 7aa4cb20-d452-417f-afdb-307df754ed75
Route
TOPICAL
Published
Effective Date 2022-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Arnica Montana Flower C13-14 Isoparaffin Elosulfase Alfa Emu Oil Diethylene Glycol Monoethyl Ether Ethylhexylglycerin Glucosamine Sulfate Isopropyl Palmitate Laureth-7 Tea Tree Oil Dimethyl Sulfone Phenoxyethanol Polyacrylamide (10000 Mw) Propylene Glycol Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-20

Description

4% Lidocaine

Purpose

External Anesthetic


Medication Information

Purpose

External Anesthetic

Description

4% Lidocaine

Uses

For temporary relief of pain and itching due to minor skin irritations.

Warnings

For external use only.

Avoid contact with eyes.

Do not usein large quantities, particularly over raw surface or blistered areas 

Stop use and ask doctor if

Condition worsens or if symptons persists more than 7 days or clear up and occur again within a few days. Discontinue use.

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: consult a physician.

Drug Facts

Active Ingredient

4% Lidocaine

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Floweri Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

Question Or Comments

FDA Registered : [email protected]

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For temporary relief of pain and itching due to minor skin irritations.

Purpose

External Anesthetic

Warnings

For external use only.

Avoid contact with eyes.

Do not usein large quantities, particularly over raw surface or blistered areas 

Stop use and ask doctor if

Condition worsens or if symptons persists more than 7 days or clear up and occur again within a few days. Discontinue use.

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: consult a physician.

Drug Facts

Active Ingredient (Active ingredient)

4% Lidocaine

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), Arnica Montana Floweri Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

Question Or Comments (Question or Comments)

FDA Registered : [email protected]

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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