FDA.reportPublic FDA data

Antibacterial hand sanitizer

Manufacturer
Ankit LLC
Effective date
2020-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:44

Label at a glance#

ProductAntibacterial hand sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Eliminate bacteria and viral matter on the skin.

Dosage and administration

Dispense a liberal amount of product on hands, enough to coat palms and fingers and then rub until dry. Supervise small children to ensure proper usage and prevent ingestion.

Storage and handling

Store below 110°F[43°C]. May discolor certain fabrics/surfaces.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Eliminate bacteria and viral matter on the skin.

Warnings

WARNINGS SECTION

Do not use

  • on children under 2 months of age
  • on open wounds

When using:

Avoid contact with face. eyes. and broken skin. In case of eye contact, flush with clean water and seek medical assistance.

Stop use and contact a doctor if:
Irritation or redness occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of ingestion. seek medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Dispense a liberal amount of product on hands, enough to coat palms and fingers and then rub until dry.
  • Supervise small children to ensure proper usage and prevent ingestion.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110°F[43°C].
  • May discolor certain fabrics/surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Aloe, Carbomer, Triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047755ethanol 75 % Topical SolutionPSN1
1047755ethanol 0.75 ML/ML Topical SolutionSCD1
1047755ethanol 75 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78887-001-012022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-022022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-032022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-042022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-052022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-062022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-072022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-082022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-092022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-102022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-112022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-122022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-132022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-142022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-152022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-162022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-172022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-182022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-192022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-202022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-212022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-222022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-232022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-242022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-252022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5
78887-001-262022-01-28C16284748780-1d6a99b39-8e75-a426-e053-dadaa90af4c239f3126d-475c-41a3-84ae-110201249df5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78887-001-01Antibacterial hand sanitizer29 mL in 1 BOTTLE, PLASTICLIQUID291
78887-001-02Antibacterial hand sanitizer59 mL in 1 BOTTLE, PLASTICLIQUID591
78887-001-03Antibacterial hand sanitizer100 mL in 1 BOTTLE, PLASTICLIQUID1001
78887-001-04Antibacterial hand sanitizer118 mL in 1 BOTTLE, PLASTICLIQUID1181
78887-001-05Antibacterial hand sanitizer237 mL in 1 BOTTLE, PLASTICLIQUID2371
78887-001-06Antibacterial hand sanitizer250 mL in 1 BOTTLE, PLASTICLIQUID2501
78887-001-07Antibacterial hand sanitizer473 mL in 1 BOTTLE, PLASTICLIQUID4731
78887-001-08Antibacterial hand sanitizer500 mL in 1 BOTTLE, PLASTICLIQUID5001
78887-001-09Antibacterial hand sanitizer887 mL in 1 BOTTLE, PLASTICLIQUID8871
78887-001-10Antibacterial hand sanitizer946 mL in 1 BOTTLE, PLASTICLIQUID9461
78887-001-11Antibacterial hand sanitizer1000 mL in 1 BOTTLE, PLASTICLIQUID10001
78887-001-12Antibacterial hand sanitizer2000 mL in 1 BOTTLE, PLASTICLIQUID20001
78887-001-13Antibacterial hand sanitizer3000 mL in 1 BOTTLE, PLASTICLIQUID30001
78887-001-14Antibacterial hand sanitizer3800 mL in 1 BOTTLE, PLASTICLIQUID38001
78887-001-15Antibacterial hand sanitizer4000 mL in 1 BOTTLE, PLASTICLIQUID40001
78887-001-16Antibacterial hand sanitizer5000 mL in 1 BOTTLE, PLASTICLIQUID50001
78887-001-17Antibacterial hand sanitizer7600 mL in 1 BOTTLE, PLASTICLIQUID76001
78887-001-18Antibacterial hand sanitizer10000 mL in 1 BOTTLE, PLASTICLIQUID100001
78887-001-19Antibacterial hand sanitizer11400 mL in 1 BOTTLE, PLASTICLIQUID114001
78887-001-20Antibacterial hand sanitizer18900 mL in 1 BOTTLE, PLASTICLIQUID189001
78887-001-21Antibacterial hand sanitizer20000 mL in 1 BOTTLE, PLASTICLIQUID200001
78887-001-22Antibacterial hand sanitizer37900 mL in 1 BOTTLE, PLASTICLIQUID379001
78887-001-23Antibacterial hand sanitizer50000 mL in 1 BOTTLE, PLASTICLIQUID500001
78887-001-24Antibacterial hand sanitizer100000 mL in 1 BOTTLE, PLASTICLIQUID1000001
78887-001-25Antibacterial hand sanitizer150000 mL in 1 BOTTLE, PLASTICLIQUID1500001
78887-001-26Antibacterial hand sanitizer200000 mL in 1 BOTTLE, PLASTICLIQUID2000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78887-001ANTIBACTERIAL HAND SANITIZER (ALCOHOL) LIQUID [ANKIT LLC]1Legacy NDC, 26 package rows20200616_39f3126d-475c-41a3-84ae-110201249df5.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
78887-00178887-001-01, 78887-001-02, 78887-001-03, 78887-001-04, 78887-001-05, 78887-001-06, 78887-001-07, 78887-001-08, 78887-001-09, 78887-001-10, 78887-001-11, 78887-001-12, 78887-001-13, 78887-001-14, 78887-001-15, 78887-001-16, 78887-001-17, 78887-001-18, 78887-001-19, 78887-001-20, 78887-001-21, 78887-001-22, 78887-001-23, 78887-001-24, 78887-001-25, 78887-001-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT

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
5057eaa2-8fca-4644-b35b-4831aa48d58839f3126d-475c-41a3-84ae-110201249df52020-06-14WarningsExact identifier
spl id: 5057eaa2-8fca-4644-b35b-4831aa48d588
spl set id: 39f3126d-475c-41a3-84ae-110201249df5

Reported adverse events (FAERS/openFDA)#

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