FDA.reportPublic FDA data

STRATAMEDI Hand Sanitizer Antibacterial Gel

Manufacturer
Strata USA LLC
Effective date
2020-05-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:46

Label at a glance#

ProductSTRATAMEDI Hand Sanitizer Antibacterial Gel
Active ingredientALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Hand Sanitizer. Kills over 99.99% of most common germs within seconds. Our Sanitizer allows you to wash your hands whenever conventional soap and water are not avialble. Use as an aid to reduce exposure to infectious germs and to supplement daily handwashing..Meet US Government standards by protecting against exposure to bloodborne diseases

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%...........................Antimicrobial

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Carbomer

WARNINGS SECTION

Flammable. Keep away from flame. Keep out of eyes. In case of eye contact immediately flush eyes with water then contact physician. If swallowed, contact physician. Keep out of reach of children. Do not store above 110°F

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

Children under 6 years of age should be supervised when using our products

INDICATIONS & USAGE SECTION

Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 mL NDC 77004-20141 250 ml label250 ml label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

StrataMedi16 oz 472mLStrataMedi16 oz 472mLStrataMedi 16 ozStrataMedi 16 oz3785 ml 1 Gallon label3785 ml 1 Gallon label3885 ml NDC 77004-2014-3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77004-202-412022-01-28C16284748780-1d6a99b39-402e-a426-e053-dadaa90af4c2STRATAMEDI Ethyl Alcohol Sanitizer
77004-202-422022-01-28C16284748780-1d6a99b39-402e-a426-e053-dadaa90af4c2STRATAMEDI Ethyl Alcohol Sanitizer
77004-202-432022-01-28C16284748780-1d6a99b39-402e-a426-e053-dadaa90af4c2STRATAMEDI Ethyl Alcohol Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77004-202-41STRATAMEDI Hand Sanitizer Antibacterial Gel250 mL in 1 BOTTLE, PLASTICGEL2501
77004-202-42STRATAMEDI Hand Sanitizer Antibacterial Gel472 mL in 1 BOTTLE, PLASTICGEL4721
77004-202-43STRATAMEDI Hand Sanitizer Antibacterial Gel3785 mL in 1 BOTTLE, PLASTICGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77004-202STRATAMEDI HAND SANITIZER ANTIBACTERIAL GEL (HAND SANITIZER) GEL [STRATA USA LLC]1Legacy NDC, 3 package rows20200616_a6f9d140-7f46-c718-e053-2995a90aeded.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77004-20277004-202-41, 77004-202-42, 77004-202-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
a6f9d140-7f47-c718-e053-2995a90aededa6f9d140-7f46-c718-e053-2995a90aeded2020-05-31WarningsExact identifier
spl id: a6f9d140-7f47-c718-e053-2995a90aeded
spl set id: a6f9d140-7f46-c718-e053-2995a90aeded

Reported adverse events (FAERS/openFDA)#

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