SPL v1
SPL
SPL Set ID 65985de0-c03e-4067-9439-317d0d4ed196
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 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-09-27

Description

Benzalkonium chloride, 0.13%

Purpose

Antiseptic hand sanitizer


Medication Information

Purpose

Antiseptic hand sanitizer

Description

Benzalkonium chloride, 0.13%

Uses

To decrease bacteria on the skin.

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

SafeThePlanet

Manufactured for safeHands, LLC, Boca Raton, FL

Patent Pending 61/473 385

Made in the USA

Section 51945-4

safeHands® Squirts® 4 Kids

Alcohol Free

Hand Sanitizer

Kills 99.9% of germs.

• Non-toxic

• Non-flammable

• Non-skin drying

Bubble Gum

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 temperature.

Questions/comments?

Call toll free 888-338-1338

Inactive Ingredients

Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Propylene glycol, Triethylene glycol, Polysorbate 20, Fragrance, D&C Red No. 33.

Stop Use and Ask A Doctor

if skin irritation develops

Keep Out of Reach of Chlidren

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


Structured Label Content

Uses

To decrease bacteria on the skin.

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

SafeThePlanet

Manufactured for safeHands, LLC, Boca Raton, FL

Patent Pending 61/473 385

Made in the USA

Section 51945-4 (51945-4)

safeHands® Squirts® 4 Kids

Alcohol Free

Hand Sanitizer

Kills 99.9% of germs.

• Non-toxic

• Non-flammable

• Non-skin drying

Bubble Gum

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 (Do not use)

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

Active Ingredient

Benzalkonium chloride, 0.13%

Other Information

Avoid extreme temperature.

Questions/comments? (Questions/Comments?)

Call toll free 888-338-1338

Inactive Ingredients

Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Propylene glycol, Triethylene glycol, Polysorbate 20, Fragrance, D&C Red No. 33.

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

if skin irritation develops

Keep Out of Reach of Chlidren (Keep out of reach of chlidren)

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


Advanced Ingredient Data


Raw Label Data

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