INCREDIBLE PRODUCTS ANTIBACTERIAL HAND GEL (HAND SANITIZER)

TriCleanz by

Drug Labeling and Warnings

TriCleanz by is a Otc medication manufactured, distributed, or labeled by Incredible Products, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRICLEANZ- hand sanitizer solution 
Incredible Products, S.A. de C.V.

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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INCREDIBLE PRODUCTS ANTIBACTERIAL HAND GEL (HAND SANITIZER)

IMPORTER OF RECORDS

FOUR TITANS LLC

16 CHESTWOOD MANOR CT

THE WOODLANS, TX 77382

TAX-ID: 85-0990083

Active Ingredient(s)

Alcohol 80% 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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

TRICLEANZ 
hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71761-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	18.425 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71761-001-00	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	08/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	08/21/2020

Labeler - Incredible Products, S.A. de C.V. (815397500)

Registrant - Incredible Products, S.A. de C.V. (815397500)

Establishment
Name	Address	ID/FEI	Business Operations
Incredible Products, S.A. de C.V.		815397500	manufacture(71761-001)

Revised: 5/2022

Document Id: de5b2643-fb02-3d31-e053-2a95a90a28c4

34390-5

Set id: 91a97efb-cb25-4aa0-bc22-7065125591dc

Version: 4

Effective Time: 20220506