HAND SANITIZER

Manufacturer
Emilia Cosmetics Ltd
Effective date
2020-05-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:14:24

Label at a glance#

ProductHAND SANITIZER 70 PERCENT
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN

Dosage and administration

PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS BRISKLY TOGETHER UNTIL DRY. CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT. NOT RECOMMENDED FOR INFANTS.

Storage and handling

STORE BELOW 110°F (43°C) MAY DISCOLOR CERTAIN FABRICS OR SURFACE.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ETHYL ALCOHOL 70% V/V

PURPOSE

OTC - PURPOSE SECTION

ANTIMICROBIAL

USES

INDICATIONS & USAGE SECTION

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

FLAMMABLE, KEEP AWAY FROM OPEN FIRE OR FLAME.

WHEN USING THIS PRODUCT DO NOT USE NEAR THE EYES. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH AND LASTS.

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

  • PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS BRISKLY TOGETHER UNTIL DRY.
  • CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.
  • NOT RECOMMENDED FOR INFANTS.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • STORE BELOW 110°F (43°C)
  • MAY DISCOLOR CERTAIN FABRICS OR SURFACE.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, ETHYLHEXYLGLYCERIN, PANTHENOL (PRO-VITAMIN B5), FRAGRANCE.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_sani-X gel_front01b LBL_sani-X gel_front

01b LBL_sani-X gel_DF Box01b LBL_sani-X gel_DF Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43219-104-022022-01-28C16284748780-1d6a99b39-72f1-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43219-104-02HAND SANITIZER70 PERCENT2 mL in 1 POUCHGEL23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43219-104HAND SANITIZER 70 PERCENT (ETHYL ALCOHOL) GEL [EMILIA COSMETICS LTD]3Legacy NDC, 1 package rows20200524_1596ba96-037b-401c-ab54-585b90334d92.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
43219-10443219-104-02

Ingredients#

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

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

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
53b1052e-b0dd-45ba-a844-ae3e64329d321596ba96-037b-401c-ab54-585b90334d922020-05-23WarningsExact identifier
spl id: 53b1052e-b0dd-45ba-a844-ae3e64329d32
spl set id: 1596ba96-037b-401c-ab54-585b90334d92

Reported adverse events (FAERS/openFDA)#

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