ANTI-MICROBIAL ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid 
Ultra Chem Labs

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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Benzalkonium Chloride 0.13%

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

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water

Directions • Pump a small amount of foam into palm of hand • Rub thoroughly over all surfaces of both hands for 15 seconds • Rinse with potable water

Inactive ingredients Water, laurtrimonium chloride, alkyl polyglucoside, uv indicator cocamidopropylamine oxide, alkyl polyglycoside, citric acid

Warnings
For external use only

Pump a small amount of foam into palm of hand • Rub thoroughly over all surfaces of both hands for 15 seconds • Rinse with potable water


• For hand washing to decrease bacteria on the skin
• Recommended for repeated use

Antimicrobial

Anti-Microbial Alcohol Free Foaming Hand Sanitizer

ANTI-MICROBIAL ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79208-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.2 mg  in 1 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79208-001-5050 mg in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
2NDC:79208-001-32946 mg in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
3NDC:79208-001-013785 mg in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/2020
Labeler - Ultra Chem Labs (082020340)
Registrant - Ultra Chem Labs (082020340)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Chem Labs, Corp082020340manufacture(79208-001)

Revised: 8/2020
Document Id: ac14846e-41f3-37c4-e053-2a95a90a3cdd
Set id: a84ec7b9-121c-498a-e053-2995a90a900b
Version: 2
Effective Time: 20200804
 
Ultra Chem Labs