Pure and Protected Hand Sanitizing Liquid

Pure and Protected Hand Sanitizing Liquid by

Drug Labeling and Warnings

Pure and Protected Hand Sanitizing Liquid 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 LIQUID- 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.

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Pure and Protected Hand Sanitizing Liquid

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, aloe vera barbadenis leaf extract

Package Label - Principal Display Panel

18mL NDC: 77506-003-06 18 ml pump bottle label

Package Label - Principal Display Panel

500 mL: NDC: 77506-003-21 500 mL Liquid Label

Packe Label - Principal Display Panel

1 Gal; NDC: 77506-003-26 1 Gal Label

Package Label - Principal Display Panel

5 L; NDC: 77506-003-27 5 L Label Image

Package Label - Principal Display Panel

1L NDC: 77506-003-24 1L Label image

PURE AND PROTECTED HAND SANITIZING LIQUID 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77506-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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) 99.25 mL  in 100 mL
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q) 0.01 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77506-003-21500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/06/202003/29/2022
2NDC: 77506-003-263780 mL in 1 BOTTLE; Type 0: Not a Combination Product08/06/202011/05/2021
3NDC: 77506-003-275000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/06/202011/05/2021
4NDC: 77506-003-241000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/06/202003/29/2022
5NDC: 77506-003-0618 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/06/202011/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/06/202003/29/2022
Labeler - Uniters SPA (442983326)
Registrant - Uniters SPA (442983326)
Establishment
NameAddressID/FEIBusiness Operations
Uniters SPA442983326manufacture(77506-003)

Revised: 3/2022
 

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