SPL v1
SPL
SPL Set ID ad8c8d98-d9fc-47f0-8cee-0793fec5e66b
Route
TOPICAL
Published
Effective Date 2023-08-17
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 Chondroitin Sulfate (bovine) Emu Oil Diethylene Glycol Monoethyl Ether Ethylhexylglycerin Glucosamine Sulfate Isopropyl Palmitate Laureth-7 Tea Tree Oil Dimethyl Sulfone Phenoxyethanol Polyacrylamide (crosslinked; 2 Mole Percent Bisacrylamide) Propylene Glycol Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-03-31

Description

Lidocaine 4%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Lidocaine 4%

Uses

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

Warnings

For external use only. Avoid contact with eyes. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center immediately.

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. Apply in a circular motion for 30 to 60 seconds.

Drug Facts

Product Label

Active Ingredient

Lidocaine 4%

Other Information

Protect this product from excessive heat and direct sun. Never tested on animals, just late clients.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexyglycerin,

Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol,

Polyacrylamide, Propylene Glycol,StearicAcid,Triethanolamine.

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 irritation.

Purpose

External Analgesic

Warnings

For external use only. Avoid contact with eyes. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center immediately.

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. Apply in a circular motion for 30 to 60 seconds.

Drug Facts

Product Label (Product label)

Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)

Protect this product from excessive heat and direct sun. Never tested on animals, just late clients.

Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexyglycerin,

Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol,

Polyacrylamide, Propylene Glycol,StearicAcid,Triethanolamine.

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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