85817-003

85817-003
SPL v1
SPL
SPL Set ID 3a221dd2-e945-bd0e-e063-6294a90a8fb9
Route
TOPICAL
Published
Effective Date 2025-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Aloe Barbadensis Leaf Commiphora Myrrha Resin Helianthus Annuus (sunflower) Seed Oil Glycerin Ginger Isopropyl Palmitate Camellia Japonica Flower Camphor, (-)- Pentylene Glycol Macropiper Methysticum Whole Alpha-tocopherol Acetate Peg-100 Stearate Piper Methysticum Root Aqua Glyceryl Stearate Menthol Panthenol Cetyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-17

Description

Lidocaine 4% (w/w)

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Lidocaine 4% (w/w)

Use

· Temporarily relieves pain and itching due to:

minor burns, sunburn, insect bites, scrapes, minor skin irritations.

Stop Use

· Condition worsens or does not improve within 7 days.

·Allergic reaction occurs to ingredients in this product.

· Symptom being treated does not subside or if redness, irritation.

Warnings

For external use only.

Ask Doctor

· Condition worsens or does not improve within 7 days.

·Allergic reaction occurs to ingredients in this product.

· Symptom being treated does not subside or if redness, irritation.

Directions

· Cleanse targeted skin area, pat dry.

· Apply a thin layer to the affected area, not more than 3–4 times daily.

Do Not Use

· on large areas of the body.

· on broken, blistered, or abraded skin.

· if allergic to local anesthetics such as lidocaine, benzocaine, or other "caine" derivatives.

When Using

· avoid contact with the eyes

· do not bandage tightly or use with heating pad

· use only as directed

Active Ingredient

Lidocaine 4% (w/w)

Other Information

· Store at 15–30°C (59–86°F)

· Protect from excessive heat and direct sunlight

· Use only as directed

Inactive Ingredients

Aqua, Glycerin, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract,

Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Stearate,

Pentylene Glycol, Cetyl Alcohol, Piper Methysticum Leaf/Root/Stem Extract, Peg-100 Stearate, Tocopheryl Acetate, Panthenol, Camellia Japonica Flower Extract,

Zingiber Officinale (Ginger) Root Extract, Commiphora Myrrha Extract, Camphor, Menthol, Lecithin.

Principal Display Panel

Keep Out of Reach of Children

If swallowed, get medical help or contact a poison control center right away.


Structured Label Content

Use

· Temporarily relieves pain and itching due to:

minor burns, sunburn, insect bites, scrapes, minor skin irritations.

Purpose

External analgesic

Stop Use

· Condition worsens or does not improve within 7 days.

·Allergic reaction occurs to ingredients in this product.

· Symptom being treated does not subside or if redness, irritation.

Warnings

For external use only.

Ask Doctor

· Condition worsens or does not improve within 7 days.

·Allergic reaction occurs to ingredients in this product.

· Symptom being treated does not subside or if redness, irritation.

Directions

· Cleanse targeted skin area, pat dry.

· Apply a thin layer to the affected area, not more than 3–4 times daily.

Do Not Use (Do not use)

· on large areas of the body.

· on broken, blistered, or abraded skin.

· if allergic to local anesthetics such as lidocaine, benzocaine, or other "caine" derivatives.

When Using

· avoid contact with the eyes

· do not bandage tightly or use with heating pad

· use only as directed

Active Ingredient

Lidocaine 4% (w/w)

Other Information (Other information)

· Store at 15–30°C (59–86°F)

· Protect from excessive heat and direct sunlight

· Use only as directed

Inactive Ingredients (Inactive ingredients)

Aqua, Glycerin, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract,

Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Stearate,

Pentylene Glycol, Cetyl Alcohol, Piper Methysticum Leaf/Root/Stem Extract, Peg-100 Stearate, Tocopheryl Acetate, Panthenol, Camellia Japonica Flower Extract,

Zingiber Officinale (Ginger) Root Extract, Commiphora Myrrha Extract, Camphor, Menthol, Lecithin.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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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