FDA.reportPublic FDA data

SANITIZING WIPES

Manufacturer
Emilia Cosmetics Ltd
Effective date
2020-11-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:34:23

Label at a glance#

ProductSANITIZING WIPES 70 PERCENT
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE. FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

Dosage and administration

WIPE ALL AREAS OF HANDS UNTIL THEY ARE VISIBLY CLEAN. USE ONE OR MORE WIPES AND DISPOSE IN AN APPROPRIATE TRASH CONTAINER. LET HANDS AIR DRY.

Storage and handling

STORE BETWEEN 15-30C (59-86F) AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40C (104F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ETHYL ALCOHOL 70% V/V

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USES

INDICATIONS & USAGE SECTION

HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE. FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

FLAMMABLE, KEEP AWAY FROM HEAT OR FLAME.

DO NOT USE

  • IN CHILDREN LESS THAN 2 MONTHS OF AGE
  • ON OPEN SKIN WOUNDS

WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

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.

OTHER SAFETY INFORMATION

DISCARD USED WIPES IMMEDIATELY TO PREVENT CROSS CONTAMINATION.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • WIPE ALL AREAS OF HANDS UNTIL THEY ARE VISIBLY CLEAN. USE ONE OR MORE WIPES AND DISPOSE IN AN APPROPRIATE TRASH CONTAINER. LET HANDS AIR DRY.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • STORE BETWEEN 15-30C (59-86F)
  • AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40C (104F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

AQUA, GLYCERIN, PANTHENOL, FRAGRANCE.

QUESTIONS?

OTC - QUESTIONS SECTION

CALL TOLL-FREE 1-866-942-9598 OR VISIT WWW.SANI-X.COM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_freedom wipe_single_Front01b LBL_freedom wipe_single_Front

01b LBL_freedom wipe_single_back01b LBL_freedom wipe_single_back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489307ethanol 70 % Medicated PadPSN5
1489307ethanol 0.7 ML/ML Medicated PadSCD5
1489307ethanol 70 % Medicated PadSY5
1489307ethanol 70 % Medicated WipesSY5
1489307ethyl alcohol 70 % ClothSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43219-101-012022-01-28C16284748780-1d6a99b39-9970-a426-e053-dadaa90af4c2SANITIZING WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43219-101-01SANITIZING WIPES70 PERCENT3 mL in 1 POUCHSOLUTION35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43219-101SANITIZING WIPES 70 PERCENT (ETHYL ALCOHOL) SOLUTION [EMILIA COSMETICS LTD]5Legacy NDC, 1 package rows20201130_e7eae7b8-b058-455e-a6c0-9b83621f683c.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43219-10143219-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT

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
7c4b2771-899c-4541-8d3f-f289eafd1b07e7eae7b8-b058-455e-a6c0-9b83621f683c2020-11-29WarningsExact identifier
spl id: 7c4b2771-899c-4541-8d3f-f289eafd1b07
spl set id: e7eae7b8-b058-455e-a6c0-9b83621f683c

Reported adverse events (FAERS/openFDA)#

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