FDA.reportPublic FDA data

SinoFresh Foaming Hand Sanitizer

Manufacturer
ZapVir, Inc.
Effective date
2020-09-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:28:54

Label at a glance#

ProductSinoFresh Foaming Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

Warnings

For External Use Only

When using this product

•Do not spray in eyes. If in eyes rinse with water

Stop Use and ask a Doctor

•If irritation or rash develops and lasts

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water (Aqua), Carbamide

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Benzalkonium Chloride 0.13%……………….….Antiseptic

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.

OTC - PURPOSE SECTION

Uses • Hand Sanitizer to help reduce bacteria on the skin that could cause disease

• Recommended for repeated use

DOSAGE & ADMINISTRATION SECTION

Directions • Pump enough product on your palm to thoroughly cover your hands.

• Rub together until dry.

• Children under 6 years should be supervised when using this product.

INDICATIONS & USAGE SECTION

Uses • Hand Sanitizer to help reduce bacteria on the skin that could cause disease

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

7 Oz Hand San Principal Display Panel.jpg7 Oz Hand San Principal Display Panel.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79961-001-012022-01-28C16284748780-1d6a99b39-9552-a426-e053-dadaa90af4c2SinoFresh Hand Sanitizer
79961-001-022022-01-28C16284748780-1d6a99b39-9552-a426-e053-dadaa90af4c2SinoFresh Hand Sanitizer
79961-001-032022-01-28C16284748780-1d6a99b39-9552-a426-e053-dadaa90af4c2SinoFresh Hand Sanitizer
79961-001-042022-01-28C16284748780-1d6a99b39-9552-a426-e053-dadaa90af4c2SinoFresh Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79961-001-01SinoFresh Foaming Hand Sanitizer30000 mg in 1 BOTTLE, WITH APPLICATORAEROSOL, FOAM300006
79961-001-02SinoFresh Foaming Hand Sanitizer50000 mg in 1 BOTTLE, WITH APPLICATORAEROSOL, FOAM500006
79961-001-03SinoFresh Foaming Hand Sanitizer207000 mg in 1 BOTTLE, WITH APPLICATORAEROSOL, FOAM2070006
79961-001-04SinoFresh Foaming Hand Sanitizer3800000 mg in 1 BOTTLE, WITH APPLICATORAEROSOL, FOAM38000006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79961-001SINOFRESH FOAMING HAND SANITIZER (FOAMING HAND SANITIZER) AEROSOL, FOAM [ZAPVIR, INC.]6Legacy NDC, 4 package rows20200910_aee75800-3210-5c4b-e053-2a95a90ae923.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79961-00179961-001-01, 79961-001-02, 79961-001-03, 79961-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
UREA8W8T17847WIACT
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
aee75800-3212-5c4b-e053-2a95a90ae923aee75800-3210-5c4b-e053-2a95a90ae9232020-09-08WarningsExact identifier
spl id: aee75800-3212-5c4b-e053-2a95a90ae923
spl set id: aee75800-3210-5c4b-e053-2a95a90ae923

Reported adverse events (FAERS/openFDA)#

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