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Tazza Antiseptic Hand Sanitizing Wipes

76370-0016 Tazza Antiseptic Hand Sanitizing Wipes

Approved
Approval ID

d6832e54-8256-66b5-e053-2995a90a7c8d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

Tazza Brands East, Inc.

DUNS: 117842371

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Benzalkonium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76370-0016
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzalkonium Chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (5)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
DECYL GLUCOSIDEInactive
Code: Z17H97EA6Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 0.13 g in 100 mL
Code: F5UM2KM3W7
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/10/2025

1700 Wet Wipes
4.3 in. x 7.1 in. (11 cm x 18 cm)
NDC: 76370-0016-3

1700 Label 1

1700 Label 2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/26/2022

Uses

  • to decrease bacteria on the skin
  • recommended for repeated use

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 1/26/2022

Made in China

Manufactured for Tazza Brands East, Inc.

4140 Mound Road, Joliet, IL 60436

877-837-7210

www.tazzabrands.com

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/26/2022

Active ingredient

Benzalkonium chloride 0.13%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/26/2022

Purpose

Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 1/26/2022

Warnings

For external use only

When using this productkeep away from eyes. In case of eye contact, rinse eyes with water.

Stop use and ask a doctor ifirritation or redness develop or last more than 72 hours.

**Keep out of reach of children.**If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/26/2022

Directions

  • rub wipe thoroughly over all surfaces of both hands
  • allow to dry without wiping
  • supervise children under 6 years old
  • not recommended for infants
  • dispose of wipe in trash; do not fliush

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/26/2022

Inactive ingredientsAloe Barbadensis Leaf Juice, Decyl Glucoside, Glycerin, Purified Water.

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