ACS ANTISEPTIC HAND SANITIZER FOAM

ACS ANTISEPTIC HAND SANITIZER FOAM by

Drug Labeling and Warnings

ACS ANTISEPTIC HAND SANITIZER FOAM by is a Otc medication manufactured, distributed, or labeled by American Chemical Systems II, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACS ANTISEPTIC HAND SANITIZER FOAM- benzalkonium chloride liquid 
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 ANTISEPTIC HAND SANITIZER FOAM

Drug Facts

Active ingredient

Benzalkonium chloride .13%

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use 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 with product and allow to dry without wiping
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

WARNING
Harmful if Swallowed.

SDS    Tech Sheet

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

Packaging

ACS ANTISEPTIC HAND SANITIZER FOAM 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75044-251
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75044-251-30	3 in 1 BOX	06/20/2020	12/29/2023
1		1000 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/20/2020	12/29/2023

Labeler - American Chemical Systems II, LLC (016631058)

Establishment
Name	Address	ID/FEI	Business Operations
American Chemical Systems II, LLC		016631058	manufacture(75044-251)

Revised: 3/2022

Document Id: cd5735b6-80d8-4bd1-8697-a9a2b7709100

34390-5

Set id: a3bc0ff3-6f13-4c50-882c-181173e5f750

Version: 2

Effective Time: 20220311