UPP-A MPCC Travel Safe Cloth

Travel Safe Hand Sanitizer by

Drug Labeling and Warnings

Travel Safe Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Uniters SPA, UNITERS SPA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRAVEL SAFE HAND SANITIZER- benzalkonium chloride cloth 
Uniters SPA

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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UPP-A MPCC Travel Safe Cloth

Active Ingredient(s)

Benzalkonium Chloride 0.1% 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.

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

• Apply thoroughly to hands
• Allow to dry without wiping
• Do not flush

Inactive ingredients

Purified water USP, ppg-2 methyl ether, decyl glucoside, c8-10/propylene glycol/peg-22/decylene glycol ether, sodium 2-acrylamido-2-methyl-1-propane sulfonate/sodium acrylate/n-isopropylacrylamide/trimethyl(3-methacrylamidopropyl) ammonium chloride copolymer, citric acid, bronopol, octhilinone

Package Label - Principal Display Panel

8 mL NDC: 77506-005-37 (7.87 in x 8.66 in) (20 cm x 22 cm)

Package label - Principal Display Panel

3.5 mL NDC: 77506-005-00 (7.48 in x 5.31 in) (19 cm x 13.5 cm)

TRAVEL SAFE HAND SANITIZER 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77506-005
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)	1 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.0148 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	98.5562 mL  in 100 mL
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)	0.2072 mL  in 100 mL
SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)	0.043 mL  in 100 mL
C8-10/PROPYLENE GLYCOL/PEG-22/DECYLENE GLYCOL ETHER (UNII: F8S8XRX18H)	0.074 mL  in 100 mL
BRONOPOL (UNII: 6PU1E16C9W)	0.004 mL  in 100 mL
OCTHILINONE (UNII: 4LFS24GD0V)	0.0008 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77506-005-00	150 in 1 BOX	08/26/2020	11/10/2021
1		3.5 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 77506-005-37	500 in 1 BOX	08/26/2020	11/10/2021
2		8 mL in 1 PACKAGE; 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	08/26/2020	09/21/2022

Labeler - Uniters SPA (442983326)

Registrant - Uniters SPA (442983326)

Establishment
Name	Address	ID/FEI	Business Operations
UNITERS SPA		442983326	manufacture(77506-005)

Revised: 9/2022

Document Id: e9321e68-31e4-6a16-e053-2995a90a31a1

34390-5

Set id: a8ebda98-7349-0637-e053-2995a90a0739

Version: 4

Effective Time: 20220921