SANITAXE ANTIBACTERIAL AMBER HAND- chloroxylenol 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 ingredients

Chloroxylenol 0.1 percent

Purpose

Antibacterial

Uses

for handwashing to eliminate bacterial and germs on the skin.

Warnings

For external use only.

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.

Children must be supervised in use of this product.

Directions

wet hands. Apply palmful to hands. Scrub thoroughly. Rinse.

Other information

Inactive ingredients

Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Glycerin, Sodium Chloride, Fragrance, Citric Acid, PEG-150 Distearate, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Yellow No.5.

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 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-118
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76176-118-01800 mL in 1 BAG; Type 0: Not a Combination Product01/01/2015
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(76176-118)

Revised: 1/2019
Document Id: 86ca5f10-e46b-8064-e053-2a91aa0ac285
Set id: 86ca5f10-e46a-8064-e053-2a91aa0ac285
Version: 1
Effective Time: 20190101
 
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.