4d7e3e0d-6884-49fa-8427-0076e2761626

SPL v2

SPL

SPL Set ID 4d7e3e0d-6884-49fa-8427-0076e2761626

Route

topical

Published

Effective Date 2014-09-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.13 g)

Inactive Ingredients

water cocamidopropyl pg-dimonium chloride phosphate propylene glycol triethylene glycol polysorbate 20 fd&c blue no. 1

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2023-01-01

Purpose

Antiseptic hand sanitizer

Description

Benzalkonium chloride, 0.13%

Medication Information

Warnings

For external use only.

Uses

To decrease bacteria on the skin.

Purpose

Antiseptic hand sanitizer

Directions

Liberally apply product to skin by gently massaging until absorbed. Supervise children in the use of this product.

Other Information

Avoid extreme temperatures.

Inactive Ingredients

Water, Cocamidolpropyl PG-Dimonium Chloride Phospate, Propylene glycol, Triethylene glycol, Polysorbate 20, Fragrance, FD&C Blue No. 1

Description

Benzalkonium chloride, 0.13%

Section 42229-5

safeHands®

Next Generation Hand Sanitizer

Kills 99.9% of germs while pampering your hands

Learn more at: www.safehands.com

A percentage of profits is donated to Safe Kids Worldwide

to “keep all kids safe from preventable injuries”

#1 Alcohol Free Brand

Manufactured for safeHands, LLC, Boca Raton, FL

Patent Pending 61/473 385

Made in the USA

Section 51945-4

safeHands®

Alcohol Free

Hand Sanitizer

Kills 99.9% of germs.

• Non-toxic

• Moisturizing

Clean Linen

Do Not Use

in eyes. In case of contact, rinse eyes thoroughly with water.

Active Ingredient

Benzalkonium chloride, 0.13%

Questions/comments?

Call toll free 888-338-1338

Stop Use and Ask A Doctor

if skin irritation develops.

Keep Out of Reach of Children

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

Structured Label Content

Warnings

For external use only.

Uses

To decrease bacteria on the skin.

Purpose

Antiseptic hand sanitizer

Directions

Liberally apply product to skin by gently massaging until absorbed. Supervise children in the use of this product.

Other Information

Avoid extreme temperatures.

Inactive Ingredients

Water, Cocamidolpropyl PG-Dimonium Chloride Phospate, Propylene glycol, Triethylene glycol, Polysorbate 20, Fragrance, FD&C Blue No. 1

Section 42229-5 (42229-5)

safeHands®

Next Generation Hand Sanitizer

Kills 99.9% of germs while pampering your hands

Learn more at: www.safehands.com

A percentage of profits is donated to Safe Kids Worldwide

to “keep all kids safe from preventable injuries”

#1 Alcohol Free Brand

Manufactured for safeHands, LLC, Boca Raton, FL

Patent Pending 61/473 385

Made in the USA

Section 51945-4 (51945-4)

safeHands®

Alcohol Free

Hand Sanitizer

Kills 99.9% of germs.

• Non-toxic

• Moisturizing

Clean Linen

Do Not Use (Do not use)

in eyes. In case of contact, rinse eyes thoroughly with water.

Active Ingredient

Benzalkonium chloride, 0.13%

Questions/comments? (Questions/Comments?)

Call toll free 888-338-1338

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if skin irritation develops.

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.

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": "COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE", "unii": "H2KVQ74JM4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHYLENE GLYCOL", "unii": "3P5SU53360", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "To decrease bacteria on the skin.", "42229-5": "safeHands® Next Generation Hand Sanitizer Kills 99.9% of germs while pampering your hands Learn more at: www.safehands.com A percentage of profits is donated to Safe Kids Worldwide to “keep all kids safe from preventable injuries” #1 Alcohol Free Brand Manufactured for safeHands, LLC, Boca Raton, FL Patent Pending 61/473 385 Made in the USA", "51945-4": "safeHands® Alcohol Free Hand Sanitizer Kills 99.9% of germs. • Non-toxic • Moisturizing Clean Linen", "Purpose": "Antiseptic hand sanitizer", "Warnings": "For external use only.", "Directions": "Liberally apply product to skin by gently massaging until absorbed. Supervise children in the use of this product.", "Do not use": "in eyes. In case of contact, rinse eyes thoroughly with water.", "Active Ingredient": "Benzalkonium chloride, 0.13%", "Other Information": "Avoid extreme temperatures.", "Questions/Comments?": "Call toll free 888-338-1338", "Inactive Ingredients": "Water, Cocamidolpropyl PG-Dimonium Chloride Phospate, Propylene glycol, Triethylene glycol, Polysorbate 20, Fragrance, FD&C Blue No. 1", "Stop use and ask a doctor": "if skin irritation develops.", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:53.539599 · Updated: 2026-03-14T23:01:12.726296