Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID fe3a9d38-937f-4a07-b230-87439c5db1d6
Route
TOPICAL
Published
Effective Date 2015-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Tea Tree Oil Fragrance Clean Orc0600327 Calendula Officinalis Flower Polyacrylic Acid (250000 Mw) Thyme Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-03-31
Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Questions? Call:



1-866-528-3721 ex. 210.







Mon-Fri 9AM to 5PM CST







Manufactured For



Electrolyzed Innovations, LLC

1747 Commerce Dr. P.O Box 1499

Piqua, OH 45356





Uses
  • For hand washing to decrease bacteria on the skin.
  • Recommended for repeated use.
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately. For children under 6, only use under adult supervision.

Warnings

For external use only.

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information
  • Store in a cool, dry place below 77°F
  • Protect from heat and light



Inactive Ingredients

Water, Calendula Oil, Fragrance Oil, Thyme Oil, Tea Tree Oil, Polyacrylic Acid
Principal Display Panel

FDA NDC # 69031-006-08

Alcohol Free

Antiseptic Gel Hand Sanitizer

Soothion

Non Dyring Formula Will Leave Your Hands Soft and Smooth

Kills 99.9% of Common Germs

Ion Dispersion Technology

Enhanced with Quality Essential Oils

8 fl oz (236 mL)

When Using This Product
avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If
  • irritation and redness develops
  • condition persists for more than 72 hours.

Structured Label Content

Uses
  • For hand washing to decrease bacteria on the skin.
  • Recommended for repeated use.
Description (34089-3)

Questions? Call:



1-866-528-3721 ex. 210.







Mon-Fri 9AM to 5PM CST







Manufactured For



Electrolyzed Innovations, LLC

1747 Commerce Dr. P.O Box 1499

Piqua, OH 45356





Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately. For children under 6, only use under adult supervision.

Purpose

Antiseptic

Warnings

For external use only.

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Other Information (Other information)
  • Store in a cool, dry place below 77°F
  • Protect from heat and light



Inactive Ingredients (Inactive ingredients)

Water, Calendula Oil, Fragrance Oil, Thyme Oil, Tea Tree Oil, Polyacrylic Acid
Principal Display Panel

FDA NDC # 69031-006-08

Alcohol Free

Antiseptic Gel Hand Sanitizer

Soothion

Non Dyring Formula Will Leave Your Hands Soft and Smooth

Kills 99.9% of Common Germs

Ion Dispersion Technology

Enhanced with Quality Essential Oils

8 fl oz (236 mL)

When Using This Product (When using this product)
avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation and redness develops
  • condition persists for more than 72 hours.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:06.248442 · Updated: 2026-03-14T22:58:57.387223