GATOR BYTE- non-alcohol hand sanitizer liquid
Reliant Technologies

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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Non-Alcohol Hand Sanitizer

Active Ingredient

Benzalkonium Chloride 0.1%

Directions : Dosage and Administration

Under Directions

Warnings

Warnings Section Warning

Inactive Ingredients

Inactive ingredients section

Usage and Indications

Usage and Indications section Usage section

Keep Out of Reach of Children

Keep Out of Reach of Children section

Purpose Section

Under purpose next to active ingredients Purpose

Packaging Label

3785 mL (1 gallon) NDC: 78094-3740-1 3785 mL label

GATOR BYTE
non-alcohol hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78094-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.05 g in 1000 g

Ingredient Name	Strength
Inactive Ingredients
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)	0.66 g in 1000 g
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)	0.5 g in 1000 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.02 g in 1000 g
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)	0.5 g in 1000 g
WATER (UNII: 059QF0KO0R)	996.82 g in 1000 g
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)	0.45 g in 1000 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:78094-001-01	100 g in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/18/2020

Labeler - Reliant Technologies (082719816)

Registrant - Reliant Technologies (082719816)

Name	Address	ID/FEI	Business Operations
Establishment
Reliant Technologies		082719816	manufacture(78094-001)