FDA.reportPublic FDA data

Little Ones

Manufacturer
Kmart Corporation | Apollo Health and Beauty Care Inc.
Effective date
2017-05-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:55

Label at a glance#

ProductLittle Ones Baby Fresh Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

to help decrease bacteria on the skin.

Storage and handling

store at a temperature below 110°F (43°C) may discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

to help decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

  • Flammable
  • Keep away from source of heat or fire.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly 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

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately. 1-800-222-1222

Directons

DOSAGE & ADMINISTRATION SECTION

  • put enough product in your palm to cover hands and rub hands together until dry
  • children under 6 years should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • store at a temperature below 110°F (43°C)
  • may discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Fragrance (Parfum), Carbomer, Aminomethyl Propanol, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Glycerin, Red 33 (CI 17200).

Questions or comments?

OTC - QUESTIONS SECTION

1-800-842-7886

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49738-413-032020-01-31C16284748780-19d75b9d0-8365-f424-e053-dadaa90a57ceDrug Facts
49738-413-072020-01-31C16284748780-19d75b9d0-8365-f424-e053-dadaa90a57ceDrug Facts
49738-413-332020-01-31C16284748780-19d75b9d0-8365-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49738-413-03Little OnesBaby Fresh Sanitizer59 mL in 1 BOTTLE, PLASTICLIQUID591
49738-413-07Little OnesBaby Fresh Sanitizer236 mL in 1 BOTTLE, PLASTICLIQUID2361
49738-413-33Little OnesBaby Fresh Sanitizer946 mL in 1 BOTTLE, PLASTICLIQUID9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49738-413LITTLE ONES BABY FRESH SANITIZER (ETHYL ALCOHOL) LIQUID [KMART CORPORATION]1Legacy NDC, 3 package rows20170524_402da4b5-bf11-4e72-8c39-95d246361ba0.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49738-41349738-413-03, 49738-413-07, 49738-413-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER 934Z135WT9208IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
glycerinPDC6A3C0OXIACT
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
00ee3b51-83ef-44b0-8d5f-ef997d59410d402da4b5-bf11-4e72-8c39-95d246361ba02017-05-23WarningsExact identifier
spl id: 00ee3b51-83ef-44b0-8d5f-ef997d59410d
spl set id: 402da4b5-bf11-4e72-8c39-95d246361ba0

Reported adverse events (FAERS/openFDA)#

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