5360a3a5-a3ad-415b-bd9a-499c2472f95a

SPL v1

SPL

SPL Set ID 5360a3a5-a3ad-415b-bd9a-499c2472f95a

Route

topical

Published

Effective Date 2019-07-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (50 mL) lidocaine (2 g)

Inactive Ingredients

benzalkonium chloride menthol water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2019-06-01

Purpose

First Aid Antiseptic Topical Analgesic

Description

Ethyl Alcohol 50.0% Lidocaine HCL 2.0%

Medication Information

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

in the eyes over large areas of the body or bandage.
in large quantities particularly over raw surfaces or blistered areas.

Stop use and contact a doctor if the condition persists or worsens for more than 7 days or clears up and occurs again within a few days.

Uses

First aid to help guard against skin infection and temporary relief of pain and itching assocaiated with insect bites.

Purpose

First Aid Antiseptic

Topical Analgesic

Directions

Adults and children 2 years and older: Apply to clean affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Inactive Ingredients

Benzalkonium Chloride, Menthol, Water.

Description

Ethyl Alcohol 50.0% Lidocaine HCL 2.0%

Packaging

Active Ingredients

Ethyl Alcohol 50.0%

Lidocaine HCL 2.0%

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.

Structured Label Content

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

in the eyes over large areas of the body or bandage.
in large quantities particularly over raw surfaces or blistered areas.

Stop use and contact a doctor if the condition persists or worsens for more than 7 days or clears up and occurs again within a few days.

Uses

First aid to help guard against skin infection and temporary relief of pain and itching assocaiated with insect bites.

Purpose

First Aid Antiseptic

Topical Analgesic

Directions

Adults and children 2 years and older: Apply to clean affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Inactive Ingredients (Inactive ingredients)

Benzalkonium Chloride, Menthol, Water.

Packaging

Active Ingredients

Ethyl Alcohol 50.0%

Lidocaine HCL 2.0%

Keep Out of Reach of Children (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

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "LIDOCAINE", "unii": "98PI200987", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "First aid to help guard against skin infection and temporary relief of pain and itching assocaiated with insect bites.", "Purpose": "First Aid Antiseptic Topical Analgesic", "Warnings": "For external use only. Flammable, keep away from fire or flame. Do not use in the eyes over large areas of the body or bandage. in large quantities particularly over raw surfaces or blistered areas. Stop use and contact a doctor if the condition persists or worsens for more than 7 days or clears up and occurs again within a few days.", "Directions": "Adults and children 2 years and older: Apply to clean affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.", "Active Ingredients": "Ethyl Alcohol 50.0% Lidocaine HCL 2.0%", "Inactive ingredients": "Benzalkonium Chloride, Menthol, Water.", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:51.689490 · Updated: 2026-03-14T22:55:37.343071