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

Purpose

First Aid Antiseptic Topical Analgesic

Description

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


Medication Information

Warnings

For external use only.

Flammable, keep away from fire or flame.

Uses

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

Purpose

First Aid Antiseptic

Topical Analgesic

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.

Inactive Ingredients

benzalkonium chloride, menthol, purified water

Description

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

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.

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

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

Warnings

For external use only.

Flammable, keep away from fire or flame.

Uses

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

Purpose

First Aid Antiseptic

Topical Analgesic

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.

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, menthol, purified water

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.

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

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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