FDA.reportPublic FDA data

Smart Sense Hand Sanitizer Cotton Breeze

Manufacturer
Kmart Corporation | Apollo Health and Beauty Care
Effective date
2016-10-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:19

Label at a glance#

ProductSmart Sense Hand Sanitizer Cotton Breeze
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

to decrease bacteria on the skin.

Dosage and administration

Apply a small amount to your palm and rub hands together briskly until dry. Children 6 years of age and under should be supervised when using this product.

Storage and handling

Store at a temperature below 110°F (43°C).

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

  • ​Flammable. Keep away from flame or fire.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or redness develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a small amount to your palm and rub hands together briskly until dry. Children 6 years of age and under should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

Store at a temperature below 110°F (43°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Propylene Glycol, Fragrance (Parfum), Benzophenone-4, Carbomer, Glycerin, Tocopheryl Acetate, Aminomethyl Propanol, Isopropyl Myristate, Blue 1 (CI 42090), Red 33 (CI 17200).

Questions or comments?

OTC - QUESTIONS SECTION

1-866-695-3030

Label Copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the labelImage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
884783ethanol 65 % Topical SolutionPSN1
884783ethanol 0.65 ML/ML Topical SolutionSCD1
884783ethanol 65 % Topical SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130883967397785GTIN-13: 0883967397785
EAN-13: 0883967397785
GTIN-12: 883967397785
UPC-A: 883967397785
GTIN storage (14 digits): 00883967397785		20833L.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49738-408-022024-01-30C16284748780-11030e365-3729-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49738-408-02Smart Sense Hand Sanitizer Cotton Breeze59 mL in 1 BOTTLE, PLASTICLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49738-408SMART SENSE HAND SANITIZER COTTON BREEZE (ETHYL ALCOHOL) LIQUID [KMART CORPORATION]1Legacy NDC, 1 package rows20161004_3165d26b-3e4b-403d-9977-36dec01ff969.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49738-40849738-408-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SULISOBENZONE1W6L629B4KIACT
CARBOMER 934Z135WT9208IACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT

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
0add8e2a-d0d8-4655-bc18-3ec5d3de46983165d26b-3e4b-403d-9977-36dec01ff9692016-10-04WarningsExact identifier
spl id: 0add8e2a-d0d8-4655-bc18-3ec5d3de4698
spl set id: 3165d26b-3e4b-403d-9977-36dec01ff969

Reported adverse events (FAERS/openFDA)#

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