85817-001

85817-001
SPL v1
SPL
SPL Set ID 37eaabb7-884e-0bd5-e063-6294a90ae063
Route
topical
Published
Effective Date 2025-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
water aloe barbadensis leaf glyceryl stearate piper methysticum root peg-100 stearate panthenol lecithin, soybean pentylene glycol alpha-tocopherol acetate menthol camphor, (-)- helianthus annuus (sunflower) seed oil glycerin isopropyl palmitate commiphora myrrha resin cetyl alcohol camellia japonica flower ginger

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-06-19

Purpose

External analgesic

Description

Lidocaine 4% (w/w)


Medication Information

Warnings

For external use only.

Purpose

External analgesic

Directions

· Cleanse targeted skin area, pat dry.

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

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.

Description

Lidocaine 4% (w/w)

Principal Display Panel

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.

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.

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)

Keep Out of Reach of Children

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


Structured Label Content

Warnings

For external use only.

Purpose

External analgesic

Directions

· Cleanse targeted skin area, pat dry.

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

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)

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.

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.

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)

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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