Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID fff6f057-739e-40f1-8427-e1364c65af05
Route
TOPICAL
Published
Effective Date 2024-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.566 mL)
Inactive Ingredients
Benzalkonium Chloride Menthol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-20

Description

Ethyl alcohol 56.6% v/v Lidocaine HCl 2.0% w/w

Purpose

First Aid Antiseptic Topical Analgesic


Medication Information

Purpose

First Aid Antiseptic

Topical Analgesic

Description

Ethyl alcohol 56.6% v/v Lidocaine HCl 2.0% w/w

Uses

First aid to help prevent infection in minor scrapes and temporary relief of itching of insect bites

Section 50566-9

Stop use and ask doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

Warnings

For external use only.

Flammable, keep away from fire or flame.

Directions

Adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily. Children under 2 years of age: Consult a doctor.

Do Not Use
  • over large areas of the body
  • in eyes
  • over raw or blistered areas
Active Ingredients

Ethyl alcohol 56.6% v/v

Lidocaine HCl 2.0% w/w

Inactive Ingredients

benzalkonium chloride, menthol, purified water

Keep Out of Reach of Children

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

Principal Display Panel – 0.8 G Pouch Label

BE SMART®

GET PREPARED

STING RELIEF

WIPE

DO NOT FLUSH

SINGLE USE

Temporary Relief from Stings & Bites

Made in USA • Manufactured forTotal Resources Inti. Inc.

Walnut, California 91789 • www.besmartgetprepared.com

00-BEE-90103 Rev.03 • NDC 55550-201 -03

1PC


Structured Label Content

Uses

First aid to help prevent infection in minor scrapes and temporary relief of itching of insect bites

Section 50566-9 (50566-9)

Stop use and ask doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

Purpose

First Aid Antiseptic

Topical Analgesic

Warnings

For external use only.

Flammable, keep away from fire or flame.

Directions

Adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily. Children under 2 years of age: Consult a doctor.

Do Not Use (Do not use)
  • over large areas of the body
  • in eyes
  • over raw or blistered areas
Active Ingredients

Ethyl alcohol 56.6% v/v

Lidocaine HCl 2.0% w/w

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, menthol, purified 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

Principal Display Panel – 0.8 G Pouch Label (Principal Display Panel – 0.8 g Pouch Label)

BE SMART®

GET PREPARED

STING RELIEF

WIPE

DO NOT FLUSH

SINGLE USE

Temporary Relief from Stings & Bites

Made in USA • Manufactured forTotal Resources Inti. Inc.

Walnut, California 91789 • www.besmartgetprepared.com

00-BEE-90103 Rev.03 • NDC 55550-201 -03

1PC


Advanced Ingredient Data


Raw Label Data

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