Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f2151af3-d76a-490f-90ff-728c350fe168
Route
TOPICAL
Published
Effective Date 2025-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Sodium Bicarbonate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-11

Description

Benzalkonium Chloride 0.13% w/w…………………………………

Purpose

First Aid Antiseptic


Medication Information

Purpose
  • First Aid Antiseptic
Description

Benzalkonium Chloride 0.13% w/w…………………………………

Use
  • Antiseptic cleansing of face, hands, and body without the use of soap and water
Section 50565-1
  • Keep out of reach of children
    • If swallowed, get medical help or contact a Poison Control Center immediately.
Section 50566-9
  • Stop use and ask a doctor if condition persist or worsens
Section 50569-3
  • Ask a doctor before use if you have deep puncture wounds, animal bites, or serious burns
Section 50570-1
  • Do not use
    • In eyes or apply over large areas of the body
    • Longer than 1 week unless directed by a doctor
    • With electrocautery procedures
Warnings
  • For external use only
Directions
  • Tear open packet, unfold and use as a washcloth
Active Ingredient
  • Benzalkonium Chloride 0.13% w/w…………………………………
Other Information
  • Store at room temperature
Inactive Ingredients
  • Sodium bicarbonate*, purified water

*may contain

Principal Display Panel

BE SMART

GET PREPARED®

ANTISEPTIC WIPE

Single Use

Do Not Flush

1pc

Made in China

Manufactured for Total Resources Intl. Inc.

Walnut, California 91789

www.besmartgetprepared.com00-TOW-94185MK Rev. 00

NDC 55550-241-02


Structured Label Content

Use (USE)
  • Antiseptic cleansing of face, hands, and body without the use of soap and water
Section 50565-1 (50565-1)
  • Keep out of reach of children
    • If swallowed, get medical help or contact a Poison Control Center immediately.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if condition persist or worsens
Section 50569-3 (50569-3)
  • Ask a doctor before use if you have deep puncture wounds, animal bites, or serious burns
Section 50570-1 (50570-1)
  • Do not use
    • In eyes or apply over large areas of the body
    • Longer than 1 week unless directed by a doctor
    • With electrocautery procedures
Purpose
  • First Aid Antiseptic
Warnings (WARNINGS)
  • For external use only
Directions (DIRECTIONS)
  • Tear open packet, unfold and use as a washcloth
Active Ingredient
  • Benzalkonium Chloride 0.13% w/w…………………………………
Other Information (OTHER INFORMATION)
  • Store at room temperature
Inactive Ingredients (INACTIVE INGREDIENTS)
  • Sodium bicarbonate*, purified water

*may contain

Principal Display Panel

BE SMART

GET PREPARED®

ANTISEPTIC WIPE

Single Use

Do Not Flush

1pc

Made in China

Manufactured for Total Resources Intl. Inc.

Walnut, California 91789

www.besmartgetprepared.com00-TOW-94185MK Rev. 00

NDC 55550-241-02


Advanced Ingredient Data


Raw Label Data

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