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

untitled

ACS ANTISEPTIC HAND SANITIZER FOAM 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75044-251
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BETAINE (UNII: 3SCV180C9W)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75044-251-303 in 1 BOX06/20/202012/29/2023
11000 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/20/202012/29/2023
Labeler - American Chemical Systems II, LLC (016631058)
Establishment
NameAddressID/FEIBusiness Operations
American Chemical Systems II, LLC016631058manufacture(75044-251)

Revised: 3/2022