66949-120 / 0901 FS Antimicrobial

Zep FS Antimicrobial Hand Cleaner by

Drug Labeling and Warnings

Zep FS Antimicrobial Hand Cleaner by is a Otc medication manufactured, distributed, or labeled by Zep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZEP FS ANTIMICROBIAL HAND CLEANER- benzalkonium chloride liquid 
Zep Inc.

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.

----------

66949-120 / 0901 FS Antimicrobial

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic Hand Wash

Uses

  • Hand washing to decrease bacteria on skin
  • For use in food processing facilities

Warnings

For external use only.

Do not use in the eyes; if in eyes, rinse promptly and thoroughly with water.

When using this product

  • Do not swallow.
  • If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.

Stop use and ask a doctor

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

Keep out of reach of children and pets

Keep out of reach of children and pets. Children must be supervised in use of this product.

Directions

  • Wet hands with water
  • Place hands under dispenser and apply liquid soap.
  • Massage soap into hands and wrists, emphasizing back of hands, knuckles and cuticles
  • Rinse hands thoroughly and dry.

Other information

  • Store at 20 to 25 ºC (68 to 77 ºF).
  • Do not freeze
  • Dispose in accordance with all applicable federal, state & local regulations

Inactive ingredients

Water, Didecyldimethylammonium Chloride, Cocamidopropyl Hydroxysultaine, Lauramine Oxide, PEG-6 Cocamide, Hydroxyethylcellusolose, Phenoxyethanol, Iodopropynyl Butylcarbamate, Methylisothiazolinone, Hexanediol, Citric Acid, Sodium Citrate

Questions or comments?

Call 1-800-I-BUY-ZEP (1-800-428-9937)

120_0901

ZEP FS ANTIMICROBIAL HAND CLEANER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66949-120
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
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
HEXANEDIOL (UNII: ZIA319275I)  
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66949-120-116000 mL in 1 CASE; Type 0: Not a Combination Product02/26/199312/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/26/199312/31/2023
Labeler - Zep Inc. (030471374)
Establishment
NameAddressID/FEIBusiness Operations
Zep Inc.112125310manufacture(66949-120)

Revised: 12/2022

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.