Triton Hand Sanitizer by Fluid USA INC / Fluids USA INC

Triton Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

TRITON HAND SANITIZER- hand sanitizer 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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Active Ingredient(s)

Alcohol 70% 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. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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.

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

• 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

Carbomer 940, Propylene Glycol USP, Isopropyl Mistrate, Imidurea, AMP-95, Purified Water USP

Package Label - Principal Display Panel

4oz NDC: 76944-970-04 8 oz NDC: 76944-970-08

16oz NDC: 76944-970-16

32oz NDC: 76944-970-32 1 Gallon NDC: 76944-970-01 330 Gallon NDC: 76944-970-30

6500 Gallon NDC: 76944-970-65

12oz NDC: 76944-970-12 0.5oz NDC: 76944-970-00

TRITON HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76944-970
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	68.77 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
IMIDUREA (UNII: M629807ATL)	0.1 kg  in 100 kg
CARBOMER 940 (UNII: 4Q93RCW27E)	0.25 kg  in 100 kg
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.15 kg  in 100 kg
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.13 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: 76944-970-30	1103 kg in 1 TANK; Type 0: Not a Combination Product	08/01/2020
2	NDC: 76944-970-01	3.34 kg in 1 PAIL; Type 0: Not a Combination Product	08/01/2020
3	NDC: 76944-970-32	0.85 kg in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020
4	NDC: 76944-970-16	0.42 kg in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020
5	NDC: 76944-970-08	0.21 kg in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020
6	NDC: 76944-970-04	0.11 kg in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020
7	NDC: 76944-970-65	21744 kg in 1 TANK; Type 0: Not a Combination Product	07/27/2020
8	NDC: 76944-970-02	0.0521 kg in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2020
9	NDC: 76944-970-00	0.00133 kg in 1 PACKET; Type 0: Not a Combination Product	09/03/2020
10	NDC: 76944-970-12	0.3187758 kg in 1 BOTTLE; Type 0: Not a Combination Product	09/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/24/2020	09/10/2021

Labeler - Fluid USA INC (117508196)

Registrant - Fluids USA INC (117508196)

Establishment
Name	Address	ID/FEI	Business Operations
Fluid USA INC		117508196	manufacture(76944-970)

Revised: 9/2021

Document Id: cbaa3ca2-c3b8-d1b4-e053-2a95a90a2c75

34390-5

Set id: a9e1b010-cd99-75e1-e053-2a95a90a0173

Version: 5

Effective Time: 20210910