FDA.reportPublic FDA data

Sani-Cardz

Manufacturer
TVG Products, LLC
Effective date
2020-10-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:32:41

Label at a glance#

ProductSani-Cardz
Active ingredientALCOHOL
Label structure10 sections

Storage and handling

Other information store between 15°-30°C (59°-86°F) avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Alcohol 80% v/v

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • hand sanitizer to help reduce bacteria that potentially can cause disease
  • for use when soap and water are not available

WARNINGS SECTION

Warnings
For external use only.

Flammable. Keep away from heat or flame.

OTC - DO NOT USE SECTION

Do not use

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • place enough product on hands to cover all surfaces
  • rub hands together until dry
  • supervise children under 6 years of age when using this product to avoid swallowing

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

MADE IN USA OF US & IMPORTED INGREDIENTS

Distributed by Sani-Cardz

2045 Biscayne Blvd #341

Miami, FL 33137

To report a serious adverse event contact 1-877-214-3305

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL ANTISEPTIC 80%
Sani-Cardz
ON-THE-GO HAND SANITIZER
TOPICAL SOLUTION
NON-STERILE SOLUTION
0.7 FL. OZ. (20ML)

sani_cardz USA-01sani_cardz USA-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80805-001-012022-07-29C16284748780-1e4f33bdf-a8a8-d8a0-e053-dadaa90a6e4eSani-Cardz Hand Sanitizer
80805-001-122022-07-29C16284748780-1e4f33bdf-a8a8-d8a0-e053-dadaa90a6e4eSani-Cardz Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80805-001-01Sani-Cardz20 mL in 1 BOTTLE, SPRAYSOLUTION202
80805-001-12Sani-Cardz12 in 1 PACKAGESOLUTION122
80805-001-12Sani-Cardz20 mL in 1 BOTTLE, SPRAYSOLUTION202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80805-001SANI-CARDZ (ALCOHOL) SOLUTION [TVG PRODUCTS, LLC]2Legacy NDC, 3 package rows20201031_b116d67e-ea35-4689-e053-2995a90ac599.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80805-00180805-001-01, 80805-001-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
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
b2ead8c2-84b0-6bc8-e053-2a95a90a9340b116d67e-ea35-4689-e053-2995a90ac5992020-10-30WarningsExact identifier
spl id: b2ead8c2-84b0-6bc8-e053-2a95a90a9340
spl set id: b116d67e-ea35-4689-e053-2995a90ac599

Reported adverse events (FAERS/openFDA)#

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