Pure and Protected Hand Sanitizing Cloth

Pure and Protected Hand Sanitizing Cloth by

Drug Labeling and Warnings

Pure and Protected Hand Sanitizing Cloth 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 CLOTH- 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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Pure and Protected Hand Sanitizing Cloth

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 occurs 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 cloth
  • Rub hands together until dry
  • Do not flush

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

3.5 mL; 150 packages per box NDC: 77506-006-00 Cloth Image Page 1

PURE AND PROTECTED HAND SANITIZING CLOTH 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77506-006
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
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 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) 99.25 mL  in 100 mL
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q) 0.01 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77506-006-00150 in 1 BOX09/14/202011/05/2021
13.5 mL in 1 PACKET; Type 0: Not a Combination Product
2NDC: 77506-006-38800 in 1 BOX09/14/202011/05/2021
23.5 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/14/202009/21/2022
Labeler - Uniters SpA (442983326)
Registrant - Uniters SpA (442983326)
Establishment
NameAddressID/FEIBusiness Operations
Uniters SpA442983326manufacture(77506-006)

Revised: 9/2022
 

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