FDA.reportPublic FDA data

StrataMedi Hand Sanitizer

Manufacturer
Strata USA LLC
Effective date
2020-08-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:25:45

Label at a glance#

ProductStrataMedi Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70%......................................Antimicrobial

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Glycerin, Propylene Glycol, Carbomer

DOSAGE & ADMINISTRATION SECTION

Our hand sanitizer allows you to wash your hands whenever conventional soal and water use are not available

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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 - PURPOSE SECTION

Kills over 99.99% of most common gerns with seconds. our hand sanitizer allows you to wash yur hands whenever conventional soap and water are not available. use as an aid to reduce exposure to infectious germs and to supplement daily handwashing. meet US government standards by protecting against exposre to bloodborne diseases.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 ml Label236 ml Label472 ml Label472 ml Label944 ml Label944 ml Label1 Gal 3785 ml label1 Gal 3785 ml label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77004-201-212021-07-23C16284748780-1c7ccaba7-1503-fd44-e053-dadaa90aa01bImpulse Antibacterial Hand Sanitizer with Isopropyl Alcohol 8oz, 16 oz 32 oz 1 Gall Gel
77004-201-222021-07-23C16284748780-1c7ccaba7-1503-fd44-e053-dadaa90aa01bImpulse Antibacterial Hand Sanitizer with Isopropyl Alcohol 8oz, 16 oz 32 oz 1 Gall Gel
77004-201-232021-07-23C16284748780-1c7ccaba7-1503-fd44-e053-dadaa90aa01bImpulse Antibacterial Hand Sanitizer with Isopropyl Alcohol 8oz, 16 oz 32 oz 1 Gall Gel
77004-201-242021-07-23C16284748780-1c7ccaba7-1503-fd44-e053-dadaa90aa01bImpulse Antibacterial Hand Sanitizer with Isopropyl Alcohol 8oz, 16 oz 32 oz 1 Gall Gel
77004-206-212021-07-23C16284748780-1c7ccaba7-1503-fd44-e053-dadaa90aa01bImpulse Antibacterial Hand Sanitizer with Isopropyl Alcohol 8oz, 16 oz 32 oz 1 Gall Gel
77004-206-222021-07-23C16284748780-1c7ccaba7-1503-fd44-e053-dadaa90aa01bImpulse Antibacterial Hand Sanitizer with Isopropyl Alcohol 8oz, 16 oz 32 oz 1 Gall Gel
77004-206-232021-07-23C16284748780-1c7ccaba7-1503-fd44-e053-dadaa90aa01bImpulse Antibacterial Hand Sanitizer with Isopropyl Alcohol 8oz, 16 oz 32 oz 1 Gall Gel
77004-206-242021-07-23C16284748780-1c7ccaba7-1503-fd44-e053-dadaa90aa01bImpulse Antibacterial Hand Sanitizer with Isopropyl Alcohol 8oz, 16 oz 32 oz 1 Gall Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77004-201-21StrataMedi Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2362
77004-201-22StrataMedi Hand Sanitizer472 mL in 1 BOTTLE, PLASTICGEL4722
77004-201-23StrataMedi Hand Sanitizer944 mL in 1 BOTTLE, PLASTICGEL9442
77004-201-24StrataMedi Hand Sanitizer378 mL in 1 BOTTLE, PLASTICGEL3782
77004-206-21Impulse Antibacterial Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2362
77004-206-22Impulse Antibacterial Hand Sanitizer472 mL in 1 BOTTLE, PLASTICGEL4722
77004-206-23Impulse Antibacterial Hand Sanitizer944 mL in 1 BOTTLE, PLASTICGEL9442
77004-206-24Impulse Antibacterial Hand Sanitizer378 mL in 1 BOTTLE, PLASTICGEL3782

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77004-201STRATAMEDI HAND SANITIZER (ISOPROPYL ALCOHOL) GEL IMPULSE ANTIBACTERIAL HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [STRATA USA LLC]2Legacy NDC, 4 package rows20200826_a6691ec8-4861-42a5-e053-2995a90a7bdc.zip
77004-206STRATAMEDI HAND SANITIZER (ISOPROPYL ALCOHOL) GEL IMPULSE ANTIBACTERIAL HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [STRATA USA LLC]2Legacy NDC, 4 package rows20200826_a6691ec8-4861-42a5-e053-2995a90a7bdc.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
77004-20177004-201-21, 77004-201-22, 77004-201-23, 77004-201-24
77004-20677004-206-21, 77004-206-22, 77004-206-23, 77004-206-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
GLYCERINPDC6A3C0OXIACT

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
adb791a6-86e5-ea3e-e053-2a95a90a0179a6691ec8-4861-42a5-e053-2995a90a7bdc2020-08-25WarningsExact identifier
spl id: adb791a6-86e5-ea3e-e053-2a95a90a0179
spl set id: a6691ec8-4861-42a5-e053-2995a90a7bdc

Reported adverse events (FAERS/openFDA)#

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