Triton Hand Sanitizer Gel

Triton Hand Sanitizer Gel by

Drug Labeling and Warnings

Triton Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Fluid USA Inc., SciencePak Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRITON HAND SANITIZER GEL- alcohol gel 
Fluid USA 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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Triton Hand Sanitizer Gel

Active Ingredient(s)

Active Ingredient(s): Ethanol 70 % v/v

Purpose

Purpose: Antiseptic

Use(s)

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

Warnings

For external use only. Flammable. Keep away from heat or flame

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Fold, snap, then squeeze to dispense product.
• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Purified Water, Propylene Glycol, Carbomer 941, Aminomethyl Propanol, Isopropyl Myristate, Imidazolidinyl Urea, t-Butyl Alcohol and/or Denatonium Benzoate

Package Label. Principal Display Panel [Clean Shot - Primary Packaging]

NDC: 76944-123-01

0.05 fl. oz (1.5 mL)

Package Label - Principal Display Panel [Bag]

250 x 0.05 fl. oz (1.5 mL) Single-Use Packets.

NDC: 76944-123-03

Package Label. Principal Display Panel [Pail]

5 gallon (20L container of 3,000 x 0.05 fl. oz (1.5 mL) Single-Use Packets.

NDC: 76944-123-04

Package Label. Principal DIsplay Panel [Box]

250 x 0.05 fl. oz (1.5 mL) Single-Use Packets.

NDC: 76944-123-02

TRITON HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76944-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62.46 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
IMIDUREA (UNII: M629807ATL)	0.1 kg  in 100 kg
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.14 kg  in 100 kg
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)	0.2 kg  in 100 kg
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.13 kg  in 100 kg
WATER (UNII: 059QF0KO0R)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)	0.001 kg  in 100 kg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	1 kg  in 100 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76944-123-02	250 in 1 BOX	09/24/2021	05/31/2023
1	NDC: 76944-123-01	0.00133 kg in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 76944-123-03	250 in 1 BAG	09/24/2021	12/20/2022
2	NDC: 76944-123-01	0.00133 kg in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 76944-123-04	3000 in 1 PAIL	09/24/2021	12/20/2022
3	NDC: 76944-123-01	0.00133 kg in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/10/2021	05/31/2023

Labeler - Fluid USA Inc. (117508196)

Registrant - Fluid USA Inc. (117508196)

Establishment
Name	Address	ID/FEI	Business Operations
SciencePak Inc.		204323385	manufacture(76944-123) , label(76944-123) , pack(76944-123) , analysis(76944-123)

Revised: 12/2022

Document Id: cdb0f73e-5043-dfec-e053-2a95a90a53f0

34390-5

Set id: cb94ba1f-aec5-a058-e053-2995a90a9b00

Version: 2

Effective Time: 20221220