ACS FOAMING ANTIBACTERIAL HANDSOAP- benzalkonium chloride soap
American Chemical Systems II, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACS FOAMING ANTIBACTERIAL HAND SOAP

Drug Facts

Active ingredient

Benzalkonium chloride .13%

Purpose

Antibacterial

Uses

for handwashing to decrease bacteria on the skin

Warnings

For external use only : hands only

Do not use

• in children less than 2 months of age
• on open skin wounds
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if

• irritation or redness develop
• condition persists for more than 72 hours

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

Directions

wet hands thoroughly
apply a small amount and work into a lather.
rinse well and dry completely
supervise children under 6 years of age when using this product to avoid swallowing

Other information

store between 15-30°C (59-86°F)
avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

aloe vera (Aloe barbadensis) leaf juice, betaine, fragrance, glycerin, propanediol, tocopheryl acetate, water

Questions?

+1-800-889-3489

You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

READ PRECAUTIONS CAREFULLY
Safety Data Sheet (SDS) is available at:
americanchemicalsystemsii.com

Foaming Antibacterial Hand Soap is a gentle, effective hand soap specially formulated to keep skin healthy and clean. It will help decrease bacteria on the skin and has a pleasant spring fragrance.

WARNING Harmful if Swallowed

As always, American Chemical Systems is working harder to make your cleaning decisions easier.

Manufactured by:
AMERICAN CHEMICAL SYSTEMS II, LLC
3505 W. 29th Street South,
Wichita, Kansas 67217

Packaging

untitled

ACS FOAMING ANTIBACTERIAL HANDSOAP
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75044-271
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 g in 1 L

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BETAINE (UNII: 3SCV180C9W)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75044-271-10	3.8 L in 1 BOTTLE; Type 0: Not a Combination Product	08/08/2020	12/20/2023
2	NDC:75044-271-20	1 L in 1 BOTTLE; Type 0: Not a Combination Product	08/08/2020	12/20/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/08/2020	12/20/2023

Labeler - American Chemical Systems II, LLC (016631058)

Name	Address	ID/FEI	Business Operations
Establishment
American Chemical Systems II, LLC		016631058	manufacture(75044-271)

Revised: 3/2022

Document Id: e26e553e-ac83-4aaf-a633-3b3d62ecd341

Set id: d397eb8b-8ed2-412c-b3cb-c1f22ed04b7a

Version: 2

Effective Time: 20220311

American Chemical Systems II, LLC