Moisturizing Hand Sanitizer - Tumi Listing

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Tumi, Inc, Uniters Spa. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol solution 
Tumi, 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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Moisturizing Hand Sanitizer - Tumi Listing

Active Ingredient(s)

Benzalkonium Chloride 0.1% v/v. Purpose: Antiseptic

Purpose

Antiseptic

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.

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 develops and continues for more than 72 hours

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 develops and continues for more than 72 hours

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

Directions

Wet hands thoroughly with product
Rub hands together until dry
Does not require rinsing

Inactive ingredients

purified water USP, polyquaternium 37 and propylene glycol dicaprylate/dicaprate and ppg-1 trideceth-6, fragrance.

Package Label - Principal Display Panel

50 mL NDC: 80196-008-08

HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80196-008(NDC: 77506-008)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)	1 mL  in 100 mL
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)	0.9 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)	0.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80196-008-08	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/08/2020	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/08/2020	10/01/2020

Labeler - Tumi, Inc (075146829)

Registrant - Uniters Spa (442983326)

Establishment
Name	Address	ID/FEI	Business Operations
Uniters Spa		442983326	manufacture(80196-008) , repack(80196-008)

Revised: 9/2020

Document Id: afed39a7-d320-65e9-e053-2995a90addf7

34390-5

Set id: ae420479-b4d9-7ef4-e053-2a95a90a96b7

Version: 2

Effective Time: 20200922