FDA.reportPublic FDA data

SANITIVA HAND SANITIZER

Manufacturer
Alpha Extractors, LLC
Effective date
2020-07-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:00

Label at a glance#

ProductSANITIVA HAND SANITIZER
Active ingredientALCOHOL
Label structure10 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 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% 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.

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.

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients glycerin USP, hydrogen peroxide USP, RODI Water, Hydroxypropyl Methylcellulose USP, Carbopol, Limonene, Linalool

SPL UNCLASSIFIED SECTION

KILLS 99.99% OF BACTERIA

WE DONATE

MADE IN USA

WWW.SANITIVA.COM

Alcohol Antiseptic 80%
Topical Solution
Hand Sanitizer
Non-sterile Solution

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78913-001-012022-01-28C16284748780-1d6a99b39-df72-a426-e053-dadaa90af4c2SANITIVA HAND SANITIZER
78913-001-102022-01-28C16284748780-1d6a99b39-df72-a426-e053-dadaa90af4c2SANITIVA HAND SANITIZER
78913-001-162022-01-28C16284748780-1d6a99b39-df72-a426-e053-dadaa90af4c2SANITIVA HAND SANITIZER
78913-001-202022-01-28C16284748780-1d6a99b39-df72-a426-e053-dadaa90af4c2SANITIVA HAND SANITIZER
78913-001-322022-01-28C16284748780-1d6a99b39-df72-a426-e053-dadaa90af4c2SANITIVA HAND SANITIZER
78913-001-402022-01-28C16284748780-1d6a99b39-df72-a426-e053-dadaa90af4c2SANITIVA HAND SANITIZER
78913-001-552022-01-28C16284748780-1d6a99b39-df72-a426-e053-dadaa90af4c2SANITIVA HAND SANITIZER
78913-001-802022-01-28C16284748780-1d6a99b39-df72-a426-e053-dadaa90af4c2SANITIVA HAND SANITIZER
78913-001-992022-01-28C16284748780-1d6a99b39-df72-a426-e053-dadaa90af4c2SANITIVA HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78913-001-01SANITIVA HAND SANITIZER3785 mL in 1 BOTTLE, PUMPSOLUTION37852
78913-001-10SANITIVA HAND SANITIZER29.57 mL in 1 BOTTLE, PUMPSOLUTION29.572
78913-001-16SANITIVA HAND SANITIZER473.17 mL in 1 BOTTLE, PUMPSOLUTION473.172
78913-001-20SANITIVA HAND SANITIZER59.14 mL in 1 BOTTLE, PUMPSOLUTION59.142
78913-001-32SANITIVA HAND SANITIZER946.35 mL in 1 BOTTLE, PUMPSOLUTION946.352
78913-001-40SANITIVA HAND SANITIZER118.29 mL in 1 BOTTLE, PUMPSOLUTION118.292
78913-001-55SANITIVA HAND SANITIZER208198 mL in 1 DRUMSOLUTION2081982
78913-001-80SANITIVA HAND SANITIZER236.58 mL in 1 BOTTLE, PUMPSOLUTION236.582
78913-001-99SANITIVA HAND SANITIZER946353 mL in 1 CONTAINERSOLUTION9463532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78913-001SANITIVA HAND SANITIZER (ALCOHOL) SOLUTION [ALPHA EXTRACTORS, LLC]2Legacy NDC, 9 package rows20200807_9272e61c-bd81-427b-af20-c35d427be938.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
78913-00178913-001-10, 78913-001-20, 78913-001-40, 78913-001-80, 78913-001-16, 78913-001-32, 78913-001-01, 78913-001-55, 78913-001-99

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
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT

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
1da4452e-3ff3-4327-a9a8-ddad3c04af739272e61c-bd81-427b-af20-c35d427be9382020-07-30WarningsExact identifier
spl id: 1da4452e-3ff3-4327-a9a8-ddad3c04af73
spl set id: 9272e61c-bd81-427b-af20-c35d427be938

Reported adverse events (FAERS/openFDA)#

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