SPL v1
SPL
SPL Set ID 37bd328e-83ba-781d-e063-6294a90ad8a4
Route
TOPICAL
Published
Effective Date 2025-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Glycerin Water Ethylhexylglycerin Phenoxyethanol Alpha-tocopherol Acetate Allantoin Carbomer Propylene Glycol Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-16

Description

Lidocaine 4% ---Topical anesthetic

Purpose

Local anesthetic


Medication Information

Purpose

Local anesthetic

Description

Lidocaine 4% ---Topical anesthetic

Uses

Temporarily helps reduce discomfort from :

Minor burns, Insect bites,linor skin irritations,Post-shaving or grooming

sensitivity,External itching or rash due to dry skin

Warnings

For external use only

Directions

▪ Adults and children over 12 years:

▪ Apply a thin layer to affected area not more than 3–4 times daily

▪ Children under 12 years: Consult a doctor before use

▪ Wash hands after application

Do Not Use:

In or near eyes

▪ On large areas of the body or on broken, blistered, or abraded skin

▪ If allergic to local anesthetics such as lidocaine

When using this product:

▪ Avoid contact with eyes

▪ Do not bandage tightly or use with heating pad

▪ Keep out of reach of children

Stop use and ask a doctor if:

▪ Condition worsens or symptoms persist more than 7 days

Redness, rash, or irritation develops

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

Active Ingredient

Lidocaine 4% ---Topical anesthetic

Other Information

Store at room temperature (15–30°C / 59–86°F)

Tamper evident: Do not use if seal is broken or missing

Inactive Ingredients

Purified Water, Glycerin, Allantoin, Tocopheryl Acetate (Vitamin E),

Carbomer, Propylene Glycol, Sodium Hydroxide, Phenoxyethanol,

Ethylhexylglycerin

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Structured Label Content

Uses

Temporarily helps reduce discomfort from :

Minor burns, Insect bites,linor skin irritations,Post-shaving or grooming

sensitivity,External itching or rash due to dry skin

Purpose (PURPOSE)

Local anesthetic

Warnings

For external use only

Directions

▪ Adults and children over 12 years:

▪ Apply a thin layer to affected area not more than 3–4 times daily

▪ Children under 12 years: Consult a doctor before use

▪ Wash hands after application

Do Not Use: (Do not use:)

In or near eyes

▪ On large areas of the body or on broken, blistered, or abraded skin

▪ If allergic to local anesthetics such as lidocaine

When using this product:

▪ Avoid contact with eyes

▪ Do not bandage tightly or use with heating pad

▪ Keep out of reach of children

Stop use and ask a doctor if:

▪ Condition worsens or symptoms persist more than 7 days

Redness, rash, or irritation develops

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

Active Ingredient (ACTIVE INGREDIENT)

Lidocaine 4% ---Topical anesthetic

Other Information (Other information)

Store at room temperature (15–30°C / 59–86°F)

Tamper evident: Do not use if seal is broken or missing

Inactive Ingredients (Inactive ingredients)

Purified Water, Glycerin, Allantoin, Tocopheryl Acetate (Vitamin E),

Carbomer, Propylene Glycol, Sodium Hydroxide, Phenoxyethanol,

Ethylhexylglycerin

Principal Display Panel (PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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