FDA.reportPublic FDA data

TZ-BKC ANTISEPTIC HAND SANITIZER

Manufacturer
T. Z. Trading, Inc.
Effective date
2020-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:28:43

Label at a glance#

ProductTZ-BKC ANTISEPTIC HAND SANITIZER
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

• hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Dosage and administration

∙ wet hands thoroughly with product and allow to dry without wiping ∙ supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

• store between 15-30 ˚C (59-86˚F) • avoid freezing and excessive heat above 40˚ C(104 ˚F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• hand sanitizer to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Warnings

WARNINGS SECTION

For external use only

Do not use

• in children less than 2 months of age

• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

∙ wet hands thoroughly with product and allow to dry without wiping

∙ supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

• store between 15-30 ˚C (59-86˚F)

• avoid freezing and excessive heat above 40˚ C(104 ˚F)

INACTIVE INGREDIENT SECTION

Inactive ingredients water

OTC - QUESTIONS SECTION

Questions?+1-281-825-5301

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Advanced Formula

Manufactured for: TZ GROUP INC., 25511 Budde Rd. Ste. 1502, The Woodlands, TX. 77380

www.tzgroupusa.com

customerservice@tzgroupusa.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75652-25275652-252-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bfce5e44-364c-4703-87e4-b58d6d1d7752beaa8213-98be-4268-b82b-cc4eb5d7bc8e2022-01-07WarningsExact identifier
spl set id: beaa8213-98be-4268-b82b-cc4eb5d7bc8e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.