G3TECH HAND SANITIZER- hand sanitizer gel 
Freshstart Holdings 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.

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Active Ingredient(s)

Benzalkonium Chloride 0.1% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For External Use Only.

Directions

Other information

Inactive ingredients

Aqua,

Glycerin,

Anthemis Nobilis (Chamomile) Flower Water,

Acrylates/C 10-30 Alkyl Acrylate Crosspolymer,

Citric Acid,

Lavandula Angustifolia (Lavender) Oil,

Aloe Barbadensis Leaf Juice,

Hydroxypropyl Methylcellulose,

Curcumin,

Korean Pine Oil

Keep out of reach of children.

Package Label - Principal Display Panel

60ml NDC: 79176-001-01 60ml label

500ml NDC: 79176-001-02

500 ml Label

1000ml NDC: 79176-001-03

1000ml label

G3TECH HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79176-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE10 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CURCUMIN (UNII: IT942ZTH98)  
WATER (UNII: 059QF0KO0R)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
WHITE PINE OIL (UNII: HA5CX6676U)  
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79176-001-20500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
2NDC:79176-001-3060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
3NDC:79176-001-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Freshstart Holdings Inc. (117553499)
Registrant - Freshstart Holdings Inc. (117553499)
Establishment
NameAddressID/FEIBusiness Operations
Freshstart Holdings Inc.117553499manufacture(79176-001)

Revised: 9/2020
Document Id: af8f7d9c-0c9e-2b04-e053-2995a90a83a0
Set id: af8f4efc-b57c-b449-e053-2a95a90ad659
Version: 4
Effective Time: 20200917
 
Freshstart Holdings Inc.