Pure and Protected Hand Sanitizing Foam

Pure and Protected Sand Sanitizing Foam by

Drug Labeling and Warnings

Pure and Protected Sand Sanitizing Foam by is a Otc medication manufactured, distributed, or labeled by Uniters SPA, UNITERS SPA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURE AND PROTECTED SAND SANITIZING FOAM- benzalkonium chloride solution 
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.

----------

Pure and Protected Hand Sanitizing Foam

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

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

Inactive ingredients

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

Package Label - Principal Display Panel

50 mL NDC: 77506-002-08

Package Label - Principal Display Panel

100 mL NDC: 77506-002-12

Package Label - Principal Display Panel

200 mL NDC: 77506-002-15

Package Label - Principal Display Panel

1000L NDC: 77506-002-36

PURE AND PROTECTED SAND SANITIZING FOAM 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77506-002
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)	0.01 mL  in 100 mL
POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)	0.15 mL  in 100 mL
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)	0.14 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77506-002-08	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/06/2020	03/29/2022
2	NDC: 77506-002-12	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/06/2020	03/29/2022
3	NDC: 77506-002-15	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/06/2020	03/29/2022
4	NDC: 77506-002-36	1000000 mL in 1 TANK; Type 0: Not a Combination Product	09/22/2020	03/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/06/2020	03/29/2022

Labeler - Uniters SPA (442983326)

Registrant - Uniters SPA (442983326)

Establishment
Name	Address	ID/FEI	Business Operations
UNITERS SPA		442983326	manufacture(77506-002)

Revised: 3/2022

Document Id: db6053c4-f5a0-ba0d-e053-2995a90a5989

34390-5

Set id: aa18319f-64e8-6baf-e053-2995a90a0172

Version: 3

Effective Time: 20220329