FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
FIFTEEN DEGREES co.,ltd | FARMER'S GRAIN KOREA LTD
Effective date
2021-01-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:36:43

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

WARNINGS SECTION

Warnings
Flammable. Keep away from fire or flame

For external use only

When using this product Do not use in or near the eyes. In case of contact,rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep Out of Reach of Children
If swallowed, get medical help or contact a Poison Control

Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

● Put enough product in your palm to cover hands and rub hands together briskly until dry

● Children under 6 years of age should be supervised when using this product

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Glycerin, Propylen Glycol, Carbomer,
Aminomethyl propanol, Citrus Limon(Lemon) Peel Oil,
Tocopheryl Acetate

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.

INDICATIONS & USAGE SECTION

Use: Hand sanitizer to help reduce bacteria on the skin

OTC - PURPOSE SECTION

purpose topical antimicrobial

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 74753-783-05

ATEM

Hand cleaner

sanitizer

ethanol 70%

500 mL (16.9 fl oz)

hand sanitizerhand sanitizer

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74753-783-052021-07-23C16284748780-1c7ccaba7-2aff-fd44-e053-dadaa90aa01bHand Sanitizer Fifteen Degrees
74753-783-252021-07-23C16284748780-1c7ccaba7-2aff-fd44-e053-dadaa90aa01bHand Sanitizer Fifteen Degrees
74753-783-502021-07-23C16284748780-1c7ccaba7-2aff-fd44-e053-dadaa90aa01bHand Sanitizer Fifteen Degrees

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74753-783-05Hand Sanitizer500 mL in 1 BOTTLELIQUID5004
74753-783-25Hand Sanitizer250 mL in 1 BOTTLELIQUID2504
74753-783-50Hand Sanitizer50 mL in 1 BOTTLELIQUID504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74753-783HAND SANITIZER (ETHYL ALCOHOL) LIQUID [FIFTEEN DEGREES CO.,LTD]4Legacy NDC, 3 package rows20210111_a302957f-f4ef-ae61-e053-2995a90a49e2.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
74753-78374753-783-05, 74753-783-50, 74753-783-25

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
LEMON OILI9GRO824LLIACT

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
b8758662-0996-5829-e053-2995a90a2075a302957f-f4ef-ae61-e053-2995a90a49e22021-01-09WarningsExact identifier
spl id: b8758662-0996-5829-e053-2995a90a2075
spl set id: a302957f-f4ef-ae61-e053-2995a90a49e2

Reported adverse events (FAERS/openFDA)#

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