FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Platinum System Inc | Les Entreprises Stefmar Inc
Effective date
2022-01-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:36

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry Supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

Store between 15-30°C (59-86°F) Avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Medicinal Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warning

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • On children less than 2 months of age
  • On open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry
  • Supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

Non-Medicinal Ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, carbomer, parfume, aloe barbadensis leaf extract, tocopheryl acetate, triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

150 mL NDC: 71316-101-14

ÉLIMINE LES GERMES
99,9%
KILLS GERMS

GelShop

HAND SANITIZER
DÉSINFECTANT
POUR LES MAINS

Alcohol antiseptic 70%
Non-sterile topical solution

Alcool antiseptique 70%
Solution topique non stérile

150 mL (5.1 Fl. Oz.)

150 mL Label150 mL Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN2
582753ethanol 0.7 ML/ML Topical SolutionSCD2
582753ethanol 70 % Topical SolutionSY2
582753ethyl alcohol 70 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78795-101-142024-01-30C16284748780-11030e365-0e36-111a-e063-dadaa90a10e2GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts
78795-101-212024-01-30C16284748780-11030e365-0e36-111a-e063-dadaa90a10e2GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts
78795-101-452024-01-30C16284748780-11030e365-0e36-111a-e063-dadaa90a10e2GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts
78795-101-502024-01-30C16284748780-11030e365-0e36-111a-e063-dadaa90a10e2GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts
78795-101-692024-01-30C16284748780-11030e365-0e36-111a-e063-dadaa90a10e2GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts
78795-101-762024-01-30C16284748780-11030e365-0e36-111a-e063-dadaa90a10e2GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts
78795-101-832024-01-30C16284748780-11030e365-0e36-111a-e063-dadaa90a10e2GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78795-101-14Hand Sanitizer150 mL in 1 TUBESOLUTION1502
78795-101-21Hand Sanitizer50 in 1 CARTONSOLUTION502
78795-101-21Hand Sanitizer3 mL in 1 PACKETSOLUTION32
78795-101-45Hand Sanitizer260 mL in 1 BOTTLESOLUTION2602
78795-101-50Hand Sanitizer50 mL in 1 TUBESOLUTION502
78795-101-69Hand Sanitizer500 mL in 1 BOTTLESOLUTION5002
78795-101-76Hand Sanitizer1000 mL in 1 BOTTLESOLUTION10002
78795-101-83Hand Sanitizer3780 mL in 1 BOTTLESOLUTION37802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78795-101HAND SANITIZER (ETHYL ALCOHOL) SOLUTION [PLATINUM SYSTEM INC]2Legacy NDC, 8 package rows20220126_a62cc8dc-e3c4-19e1-e053-2a95a90a41a6.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78795-10178795-101-45, 78795-101-69, 78795-101-76, 78795-101-83, 78795-101-21, 78795-101-14, 78795-101-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
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
d6694fb1-0f3f-6811-e053-2995a90ad485a62cc8dc-e3c4-19e1-e053-2a95a90a41a62022-01-25WarningsExact identifier
spl id: d6694fb1-0f3f-6811-e053-2995a90ad485
spl set id: a62cc8dc-e3c4-19e1-e053-2a95a90a41a6

Reported adverse events (FAERS/openFDA)#

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