FDA.reportPublic FDA data

Dr. Sam Premium Hand Sanitizer (100mL)

Manufacturer
G.E.O MARKETING CORP | Korea Medicare Co.,Ltd.
Effective date
2020-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:11

Label at a glance#

ProductDr. Sam Premium Hand Sanitizer (100mL)
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Hand sanitizer for decreasing bacteria on skin

Dosage and administration

Apply the adequate amount on hands

Label contents#

Full prescribing information#

Active ingedient

OTC - ACTIVE INGREDIENT SECTION

Ethanol (ethyl alcohol) (62%)

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer for decreasing bacteria on skin

Warnings

WARNINGS SECTION

For external use only

Do not use if you are allergic to any of the ingredients

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. avoid contact with broken, irritated, or itching skin. Do not puncture or incinerate.

Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours.

If pregnant or breast-feeding, ask a health professional before use

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply the adequate amount on hands

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Glycerin, L-menthol, Carbomer, Aminomethyl Propanol, Aloe extract

Dr. Sam Premium Hand Sanitizer (100mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

draft dr sam 100draft dr sam 100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78012-100-012022-01-28C16284748780-1d6a99b39-c11a-a426-e053-dadaa90af4c2Dr. Sam Premium Hand Sanitizer (100mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78012-100-01Dr. Sam Premium Hand Sanitizer (100mL)100 mL in 1 BOTTLEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78012-100DR. SAM PREMIUM HAND SANITIZER (100ML) (ETHYL ALCOHOL) GEL [G.E.O MARKETING CORP]1Legacy NDC, 1 package rows20200529_a6bb094c-93e6-58fa-e053-2a95a90a148b.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78012-10078012-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
LEVOMENTHOLBZ1R15MTK7IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ALOEV5VD430YW9IACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT

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
a6bb221c-acad-7fb1-e053-2995a90aa0e7a6bb094c-93e6-58fa-e053-2a95a90a148b2020-05-28WarningsExact identifier
spl id: a6bb221c-acad-7fb1-e053-2995a90aa0e7
spl set id: a6bb094c-93e6-58fa-e053-2a95a90a148b

Reported adverse events (FAERS/openFDA)#

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