SANITAXE ANTIBACTERIAL AMBER HAND 27 FL OZ- benzalkonium chloride liquid 
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.

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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Drug Facts
Active Ingredient

Benzalkonium Chloride 0.13 percent

Purpose

Antibacterial

Uses

Warnings

For external use only. Do not ingest or swallow.

Do not apply around eyes. Do not use in ears and mouth.

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

Stop use and ask a doctor

if redness or irritation develops and persists for more than 72 hours.

Keep out of reach of children.

Do not use on children less than 2 months of age. Supervise use in children under 6 years of age to prevent accidental swallowing. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients:

Water (Aqua), Cocamidopropye Betaine, Sodium Cocoamphoacetate, PEG-150 Distearate, Fragrance, Citric Acid, Methylisothiazolinone, Iodopropynyl Butylcarbamate, FD&C Yellow No.5, D&C Red No.40

Loading Instructions

1. Tear tab off of box and pull out tube. Pull down nozzle until tube extends from bottom of box.

2. Place Bag-In-Box into dispenser. Guide nozzle fitment into valve channel and close dispenser. Push button to prime.

label

SANITAXE ANTIBACTERIAL AMBER HAND 27 FL OZ 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-124
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76176-124-01800 mL in 1 BAG; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2015
Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098)
Registrant - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.530766098manufacture(76176-124)

Revised: 9/2020
Document Id: af511208-bae0-501d-e053-2a95a90aeae9
Set id: af511208-bae1-501d-e053-2a95a90aeae9
Version: 1
Effective Time: 20200901
 
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.