cleandurancetm

SPL v5

SPL

SPL Set ID 27171f80-1e8e-4a63-a61e-4fae937270b2

Route

topical

Published

Effective Date 2020-09-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.13 g)

Inactive Ingredients

water calcium silicate

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-08-01

Purpose

Skin Antiseptic

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only. Do not use in the eyes. In case of eye contact, flush thoroughly with water & seek medical attention.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Purpose

Skin Antiseptic

Directions

Dispense an adequate amount in palm to cover hands.

Rub hands together to cover skin thoroughly until dry.

Supervise young children while using this product.

Other Information

*Skin cells may be shed naturally or by abrasion prior to 4 hours, exposing fresh, unprotected skin. Reapply as needed.

Description

Benzalkonium Chloride 0.13%

Use[s]

For hand and skin sanitizing to decrease microbes on skin.

Section 42229-5

Kills 99.99% of Bacteria & Viruses

4-HR HAND SANITIZER

• NON-FLAMMABLE

• NON-TOXIC

• DYE FREE

• FRAGRANCE FREE

MADE IN THE USA

Manufactured By:

Guide Solutions

9330 S. Highway 99

Prague, OK 74864

405-567-0710

FDA Registered

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Drug Facts

purpose

Skin Antiseptic

Active Ingredient[s]

Benzalkonium Chloride 0.13%

inactive Ingredients

Water, Calcium Silicate

Structured Label Content

Warnings

For external use only. Do not use in the eyes. In case of eye contact, flush thoroughly with water & seek medical attention.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Directions

Dispense an adequate amount in palm to cover hands.

Rub hands together to cover skin thoroughly until dry.

Supervise young children while using this product.

Other Information (Other information)

*Skin cells may be shed naturally or by abrasion prior to 4 hours, exposing fresh, unprotected skin. Reapply as needed.

Use[s]

For hand and skin sanitizing to decrease microbes on skin.

Section 42229-5 (42229-5)

Kills 99.99% of Bacteria & Viruses

4-HR HAND SANITIZER

• NON-FLAMMABLE

• NON-TOXIC

• DYE FREE

• FRAGRANCE FREE

MADE IN THE USA

Manufactured By:

Guide Solutions

9330 S. Highway 99

Prague, OK 74864

405-567-0710

FDA Registered

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Drug Facts

purpose (Purpose)

Skin Antiseptic

Active Ingredient[s] (Active ingredient[s])

Benzalkonium Chloride 0.13%

inactive Ingredients (Inactive ingredients)

Water, Calcium Silicate

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM SILICATE", "unii": "S4255P4G5M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use[s]": "For hand and skin sanitizing to decrease microbes on skin.", "42229-5": "Kills 99.99% of Bacteria & Viruses 4-HR HAND SANITIZER • NON-FLAMMABLE • NON-TOXIC • DYE FREE • FRAGRANCE FREE MADE IN THE USA Manufactured By: Guide Solutions 9330 S. Highway 99 Prague, OK 74864 405-567-0710 FDA Registered", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Warnings": "For external use only. Do not use in the eyes. In case of eye contact, flush thoroughly with water & seek medical attention. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.", "Directions": "Dispense an adequate amount in palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.", "Purpose": "Skin Antiseptic", "Other information": "*Skin cells may be shed naturally or by abrasion prior to 4 hours, exposing fresh, unprotected skin. Reapply as needed.", "Active ingredient[s]": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Water, Calcium Silicate"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:58:57.674915 · Updated: 2026-03-14T22:58:46.689678