FDA.reportPublic FDA data

Sani-Sure

Manufacturer
Whisk Products, Inc.
Effective date
2024-09-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:48

Label at a glance#

ProductSani-Sure
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Place a small amount of product in one hand. Spread on hands and rub into skin until dry. Place a smaller amount in one hand and spread over both hands and wrists. Rub into skin until dry. Children should be supervised while using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 60% v/v

Purpose

OTC - PURPOSE SECTION

Skin Sanitizer

Use

INDICATIONS & USAGE SECTION

To help reduce the amount of bacteria on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only. If swallowed, seek medical attention.

When using this product do not use around or near the eyes. If contact occurs, flush eyes with water and contact doctor immediately.

Stop use and consult a doctor when skin irritation appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place a small amount of product in one hand.
  • Spread on hands and rub into skin until dry.
  • Place a smaller amount in one hand and spread over both hands and wrists.
  • Rub into skin until dry.
  • Children should be supervised while using this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Fragrance, Carbomer, Propylene Glycol, Diisopropylamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Label - 8 fl. oz. Bell Jar with PumpProduct Label - 8 fl. oz. Bell Jar with Pump

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581658ethanol 60 % Topical GelPSN1
581658ethanol 0.6 ML/ML Topical GelSCD1
581658ethanol 60 % Topical GelSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65585-359-01Sani-Sure0.237 L in 1 BOTTLE, PUMPGEL0.2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65585-359SANI-SURE (ALCOHOL) GEL [WHISK PRODUCTS, INC.]1Current NDC, 1 package rows20240906_215090ce-5f54-35e7-e063-6394a90ae655.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65585-35965585-359-01

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 INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MACTIB
DIISOPROPYLAMINEBR9JLI40NOIACT

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
Sani-SureALCOHOLWhisk Products, Inc.215090ce-5f54-35e7-e063-6394a90ae6552024-09-04WarningsExact identifier
ndc (package): 65585-359-01
ndc (product): 65585-359
ndc11 (package): 65585035901
spl id: 21508f9e-96cb-6855-e063-6394a90a57b8
spl set id: 215090ce-5f54-35e7-e063-6394a90ae655

Reported adverse events (FAERS/openFDA)#

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