Pure and Protected Hand Sanitizing Lotion

Pure and Protected Hand Sanitizing by

Drug Labeling and Warnings

Pure and Protected Hand Sanitizing by is a Otc medication manufactured, distributed, or labeled by Uniters SpA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURE AND PROTECTED HAND SANITIZING- benzalkonium chloride lotion 
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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Pure and Protected Hand Sanitizing Lotion

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.

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 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

• 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.

Inactive ingredients

purified water USP, polyquaternium-37, propylene glycol dicaprylate/dicaprate, ppg-1 trideceth-6, aloe vera barbadenis leaf extract

Package Label - Principal Display Panel

250 mL NDC: 77506-007-17

PURE AND PROTECTED HAND SANITIZING 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77506-007
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
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)	0.06 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.1 mL  in 100 mL
POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)	1.02 mL  in 100 mL
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)	0.92 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	97.55 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77506-007-17	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/06/2020	11/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/06/2020	11/10/2021

Labeler - Uniters SpA (442983326)

Registrant - Uniters SpA (442983326)

Establishment
Name	Address	ID/FEI	Business Operations
Uniters SpA		442983326	manufacture(77506-007)

Revised: 11/2021

Document Id: d072c127-facd-ee0a-e053-2995a90a18eb

34390-5

Set id: ab338596-edb5-54f9-e053-2995a90a9487

Version: 2

Effective Time: 20211110