FDA.reportPublic FDA data

Sparkled Donut

Manufacturer
GL 360
Effective date
2018-04-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:16

Label at a glance#

ProductBurger Time Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol  62%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

INDICATIONS & USAGE SECTION

Use hand sanitizer to help reduce bacteria on skin.

Warning

WARNINGS SECTION

Flammable Keep away from heat and flame

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask doctor if irritation or redness develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

■ Wet hands thoroughly with product and rub into skin until dry.
■ Children Directions
■ Wet hands thoroughly with product and rub into skin until dry.
■ Children under 6 years of age should be supervised by an
adult when using.

INACTIVE INGREDIENT SECTION

Inactive
Ingredients
Water (Aqua), Aloe Barbadensis Leaf Juice, Carbomer, Fragrance,
Glycerin, Propylene Glycol, Triethanolamine, Tocopheryl Acetate
FD&C Yellow No. 5, FD&C Blue No. 1

Product Labels for: Burger Time  Fresh Fries  Pizza Party  Sparkled Donut

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burger Time Hand Sanitizer Label

Burger Time

HAND SANITIZER

Drug Facts

Active
Ingredients
Ethyl Alcohol 62.0%

Purpose
Antimicrobial

Use hand sanitizer
to help reduce
bacteria on skin.

ADDITIONAL DRUG FACTS

Distributed By:
Personal Care Products, LLC
Troy, Michigan 48084
Made in China

Drug Facts
(continued)

Flammable Keep
away from heat and
flame

When using this
product avoid contact
with eyes. If contact
occurs, rinse
thoroughly with water.

Stop use and ask
doctor if irritation or
redness develops

Keep out of reach
of children.
If swallowed, get
medical help or
contact a Poison
Control Center
right away.

Drug Facts
(continued)

Directions
■ Wet hands
thoroughly with
product and rub
into skin until dry.
■ Children under
6 years of age
should be
supervised by an
adult when using.

Inactive
Ingredients
Water (Aqua), Aloe
Barbadensis Leaf Juice,
Carbomer, Fragrance,
Glycerin, Propylene
Glycol, Triethanolamine,
Tocopheryl Acetate
FD&C Yellow No. 5,
FD&C Blue No. 1

BrgrTimeBrgrTime

Fresh Fries Hand Sanitizer Label

FreshFriesFreshFries

Pizza Party Hand Sanitizer Label

PizzaPartyPizzaParty


Sparkled Donut Hand Sanitizer Label

SparkldDonutSparkldDonut

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
29500-9413-12020-01-31C16284748780-19d75b9d0-2485-f424-e053-dadaa90a57ceBurger Time -9413 Fresh Fries -9414 Pizza Party -9415 Sparkled Donut -9516
29500-9414-12020-01-31C16284748780-19d75b9d0-2485-f424-e053-dadaa90a57ceBurger Time -9413 Fresh Fries -9414 Pizza Party -9415 Sparkled Donut -9516
29500-9415-12020-01-31C16284748780-19d75b9d0-2485-f424-e053-dadaa90a57ceBurger Time -9413 Fresh Fries -9414 Pizza Party -9415 Sparkled Donut -9516
29500-9416-12020-01-31C16284748780-19d75b9d0-2485-f424-e053-dadaa90a57ceBurger Time -9413 Fresh Fries -9414 Pizza Party -9415 Sparkled Donut -9516

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29500-9413-1Burger TimeHand Sanitizer30 mL in 1 BOTTLE, PLASTICLIQUID302
29500-9414-1Fresh FriesHand Sanitizer30 mL in 1 BOTTLE, PLASTICLIQUID302
29500-9415-1Pizza PartyHand Sanitizer30 mL in 1 BOTTLE, PLASTICLIQUID302
29500-9416-1Sparkled DonutHand Sanitizer30 mL in 1 BOTTLE, PLASTICLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29500-9413BURGER TIME HAND SANITIZER (ALCOHOL) LIQUID FRESH FRIES HAND SANITIZER (ALCOHOL) LIQUID PIZZA PARTY HAND SANITIZER (ALCOHOL) LIQUID SPARKLED DONUT HAND SANITIZER (ALCOHOL 62%) LIQUID [GL 360]2Legacy NDC, 1 package rows20180424_bdea9a5e-bcec-43ee-9de4-658d100b4a7e.zip
29500-9414BURGER TIME HAND SANITIZER (ALCOHOL) LIQUID FRESH FRIES HAND SANITIZER (ALCOHOL) LIQUID PIZZA PARTY HAND SANITIZER (ALCOHOL) LIQUID SPARKLED DONUT HAND SANITIZER (ALCOHOL 62%) LIQUID [GL 360]2Legacy NDC, 1 package rows20180424_bdea9a5e-bcec-43ee-9de4-658d100b4a7e.zip
29500-9415BURGER TIME HAND SANITIZER (ALCOHOL) LIQUID FRESH FRIES HAND SANITIZER (ALCOHOL) LIQUID PIZZA PARTY HAND SANITIZER (ALCOHOL) LIQUID SPARKLED DONUT HAND SANITIZER (ALCOHOL 62%) LIQUID [GL 360]2Legacy NDC, 1 package rows20180424_bdea9a5e-bcec-43ee-9de4-658d100b4a7e.zip
29500-9416BURGER TIME HAND SANITIZER (ALCOHOL) LIQUID FRESH FRIES HAND SANITIZER (ALCOHOL) LIQUID PIZZA PARTY HAND SANITIZER (ALCOHOL) LIQUID SPARKLED DONUT HAND SANITIZER (ALCOHOL 62%) LIQUID [GL 360]2Legacy NDC, 1 package rows20180424_bdea9a5e-bcec-43ee-9de4-658d100b4a7e.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29500-941329500-9413-1
29500-941429500-9414-1
29500-941529500-9415-1
29500-941629500-9416-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C RED NO. 40WZB9127XOAIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C RED NO. 40WZB9127XOAIACT

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
cd5cf72c-2b32-4a55-8def-1acde8da33b8bdea9a5e-bcec-43ee-9de4-658d100b4a7e2018-04-24WarningsExact identifier
spl id: cd5cf72c-2b32-4a55-8def-1acde8da33b8
spl set id: bdea9a5e-bcec-43ee-9de4-658d100b4a7e

Reported adverse events (FAERS/openFDA)#

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