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
Description

Ethyl Alcohol 50.0% Lidocaine HCL 2.0%

Purpose

First Aid Antiseptic Topical Analgesic

Medication Information

Purpose

First Aid Antiseptic

Topical Analgesic

Description

Ethyl Alcohol 50.0% Lidocaine HCL 2.0%

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

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.

Structured Label Content

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.
Packaging

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 (Inactive ingredients)

Benzalkonium Chloride, Menthol, Water.

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

Raw Label Data

All Sections (JSON)

Additional Information

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