Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 454b1773-eda8-5610-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.025 g)
Inactive Ingredients
Camphor (synthetic) Water Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-04-15
Description

Active Ingredients Benzalkonium Cl 0.13% w/w Lidocaine HCl 2.5% w/w

Purpose

First aid antiseptic Pain reliever

Medication Information

Purpose

First aid antiseptic

Pain reliever

Description

Active Ingredients Benzalkonium Cl 0.13% w/w Lidocaine HCl 2.5% w/w

Uses

Firs aid to help prevent bacterial contamination or skin infections, and temporary relief of pain and itching associated with minor:

cuts

scrapes

burns

sunburns

skin irritations

Section 51945-4

Warnings

For external use only

Directions

Adults and children 2 years and older:

clean the affected area

apply a small amount on the area 1 to 3 times daily.

may be covered with a sterile bandage

if bandaged, let dry first.

Drug Facts

Active Ingredients

Benzalkonium Cl 0.13% w/w

Lidocaine HCl 2.5% w/w

Other Information

Protect from excessive heat.

Inactive Ingredients

Camphor, Deionized Water, Propylene Glycol

Questions Or Comments

1-800-635-3696

When Using This Product

do not use near the eyes

do not apply over large areas of the body or in large quantities

do not apply over raw surfaces or blistered areas

Stop Use and Ask A Doctor If

condition worsens

symptoms persist for more than 7 days, or clear up and occur again within a few days.

Keep Out of Reach of Children.

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

Ask Doctor Before Use If You Have

deep or puncture wounds

animal bites

serious burns

Structured Label Content

Uses

Firs aid to help prevent bacterial contamination or skin infections, and temporary relief of pain and itching associated with minor:

cuts

scrapes

burns

sunburns

skin irritations

Section 51945-4 (51945-4)

Purpose

First aid antiseptic

Pain reliever

Warnings

For external use only

Directions

Adults and children 2 years and older:

clean the affected area

apply a small amount on the area 1 to 3 times daily.

may be covered with a sterile bandage

if bandaged, let dry first.

Drug Facts

Active Ingredients

Benzalkonium Cl 0.13% w/w

Lidocaine HCl 2.5% w/w

Other Information

Protect from excessive heat.

Inactive Ingredients

Camphor, Deionized Water, Propylene Glycol

Questions Or Comments (Questions or comments)

1-800-635-3696

When Using This Product (When using this product)

do not use near the eyes

do not apply over large areas of the body or in large quantities

do not apply over raw surfaces or blistered areas

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens

symptoms persist for more than 7 days, or clear up and occur again within a few days.

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.

Ask Doctor Before Use If You Have (Ask doctor before use if you have)

deep or puncture wounds

animal bites

serious burns

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:14.373272 · Updated: 2026-03-14T22:54:35.350687