FDA.reportPublic FDA data

Smarties Hand Sanitizer

Manufacturer
Flex Beauty Labs
Effective date
2020-06-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:16:47

Label at a glance#

ProductSmarties Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

apply palmful to hands. rub hands together vigorously until dry. supervise children in the use of this product.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%.................Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

hand sanitizer to help reduce bacteria on the skin

Safety Instructions

WARNINGS SECTION

Flammable, Keep away from fire and flame

When using this product

OTC - WHEN USING SECTION

In case of contact,rinse eyes thoroughly with water

Do not use

OTC - DO NOT USE SECTION

Do  not use in or near eyes.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control  center right away.

Other Information

OTHER SAFETY INFORMATION

Store below 110°F (43°C)
May discolor certain fabrics or surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), Triethanolamine, Carbomer, Fragrance, Glycerin. Propylene Glycol,Yellow 5,Red 33.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply palmful to hands.
  • rub hands together vigorously until dry.
  • supervise children in the use of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

smartiessmarties

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN2
902574ethanol 0.65 ML/ML Topical GelSCD2
902574ethyl alcohol 65 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72308-003-012021-07-23C16284748780-1c7ccaba7-1401-fd44-e053-dadaa90aa01bSmarties Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72308-003-01Smarties Hand Sanitizer30 mL in 1 BOTTLEGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72308-003SMARTIES HAND SANITIZER (ETHYL ALCOHOL) GEL [FLEX BEAUTY LABS]2Legacy NDC, 1 package rows20200610_5ec1cbe5-42bd-4fe1-ae04-136b40a042c1.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72308-00372308-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 339DBA0SBB0LIACT
ALCOHOL3K9958V90MACTIB

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
a7ae66d6-a418-6c80-e053-2995a90a61be5ec1cbe5-42bd-4fe1-ae04-136b40a042c12020-06-09WarningsExact identifier
spl id: a7ae66d6-a418-6c80-e053-2995a90a61be
spl set id: 5ec1cbe5-42bd-4fe1-ae04-136b40a042c1

Reported adverse events (FAERS/openFDA)#

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