APPLE SCENTED HAND SANITIZER 01- benzalkonium chloride gel 
Foshan Astar Industry 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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MB0075SA，light orange, apple
Foshan Astar

Drug facts

Active ingredient purpose

Benzalkonium chloride 0.1% Antibacterial

Use

To decrease bacteria on the skin that could cause disease.

Warnings

For external use only-hands

keep out of eyes- avoid contact with broken skin

Stop use and ask a dosctor if irritation or radness develops

Do not inhale or ingest. If swallowed, get medical help or contact a poison control right away.

Direction

Rub a dime sized drop into hands.

For children under 6 use under adult supervision

Inactive ingredients

INACTIVE INGREDIENTS: WATER, GLYCERIN, COCETH-7, PPG-1-PEG-9 LAURYL GLYCOL ETHER, CARBOMER, SODIUM HYDROXIDE, PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE (PARFUM).
MAY CONTAIN: RED 40, RED 33, BLUE 1, YELLOW 5.

Questions?

1-212-779-0544 weekdays

77901-013-01

APPLE SCENTED HAND SANITIZER  01
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77901-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCETH-7 (UNII: 58Y261JLH5) 0.68 mL  in 100 mL
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L) 0.68 mL  in 100 mL
WATER O-18 (UNII: 7QV8F8BYNJ) 96 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL  in 100 mL
CARBOMER 934 (UNII: Z135WT9208) 0.24 mL  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.12 mL  in 100 mL
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 0.15 mL  in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.005 g  in 100 mL
APPLE (UNII: B423VGH5S9) 0.3 mL  in 100 mL
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.003 g  in 100 mL
Product Characteristics
ColororangeScore    
ShapeSize
FlavorAPPLEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77901-013-0159 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package06/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/30/2020
Labeler - Foshan Astar Industry Co., Ltd (421358695)
Registrant - Foshan Astar Industry Co., Ltd (421358695)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Astar Industry Co., Ltd421358695manufacture(77901-013)

Revised: 7/2021
Document Id: c6949142-c173-977e-e053-2995a90adb74
Set id: a95c2d97-a63a-23b5-e053-2995a90a3986
Version: 2
Effective Time: 20210707
 
Foshan Astar Industry Co., Ltd