Triton Hand Sanitizer by Fluid 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. 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.

----------

Active Ingredient(s)

Alcohol 65% 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

purified water USP, carbomer 940, Propelye Glycol USP, Isoproyl Myristate, Imidurea, AMP-95

Package Label - Principal Display Panel

4oz NDC: 76944-965-04 4oz label8 oz NDC: 76944-965-08

8oz Label

16oz NDC: 76944-965-16

16oz Label32oz NDC: 79644-965-32

32oz Label1 Gallon NDC: 76944-965-01

1 gallon Front1 gallon back

330 Gallon NDC: 76944-965-30

330 gallon label

TRITON HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76944-965
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 kg  in 100 kg
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.13 kg  in 100 kg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 kg  in 100 kg
WATER (UNII: 059QF0KO0R)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.13 kg  in 100 kg
IMIDUREA (UNII: M629807ATL) 0.1 kg  in 100 kg
CARBOMER 940 (UNII: 4Q93RCW27E) 0.25 kg  in 100 kg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76944-965-301121 kg in 1 TANK; Type 0: Not a Combination Product08/01/2020
2NDC: 76944-965-013.4 kg in 1 PAIL; Type 0: Not a Combination Product08/01/2020
3NDC: 76944-965-320.85 kg in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
4NDC: 76944-965-160.42 kg in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
5NDC: 76944-965-080.21 kg in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
6NDC: 76944-965-040.11 kg in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/202009/10/2021
Labeler - Fluid USA INC (117508196)
Registrant - Fluid USA INC (117508196)
Establishment
NameAddressID/FEIBusiness Operations
Fluid USA INC117508196manufacture(76944-965)

Revised: 9/2021
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.