FDA.reportPublic FDA data

NO-WASH ANTIBACTERIAL GEL

Manufacturer
MAJESTIC GROUP LLC
Effective date
2020-05-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:11:09

Label at a glance#

ProductNO-WASH ANTIBACTERIAL
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand-Sanitizer helps to reduce the amount of disease causing bacteria on the skin

Dosage and administration

Place enough product in your palm to thoroughly cover your hands.  Rub hands togerher thoroughly until dry. For children under 6 years old use only under adult supevision :Not recommended for use on infants.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Hand-Sanitizer helps to reduce the amount of disease causing bacteria on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only.

  • Do not use this hand sanitizer  on or near the eyes.In case of accidental contact, flush eyes thoroughtly with water.
  • Do not use on broken skin: Do not inhale or ingest.
  • In case of skin irritation please stop use and talk to doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover your hands. 
  • Rub hands togerher thoroughly until dry.
  • For children under 6 years old use only under adult supevision :Not recommended for use on infants.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally  swallowed,  contact the  Poison Control Center or get medical help immediately.

Other Information

SPL UNCLASSIFIED SECTION

  • Do not store above 110°F (43°C)
  • May discolor certain fabrics or surfaces

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Water(Aqua),Carbomer,Glycerin,Triethanolamine

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77331-001-012022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-022022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-032022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-042022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-052022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-062022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-072022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-082022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-092022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-102022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-112022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-122022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-132022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-142022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77331-001-01NO-WASH ANTIBACTERIAL500 mL in 1 BOTTLEGEL5002
77331-001-02NO-WASH ANTIBACTERIAL20 mL in 1 BOTTLEGEL202
77331-001-03NO-WASH ANTIBACTERIAL30 mL in 1 BOTTLEGEL302
77331-001-04NO-WASH ANTIBACTERIAL40 mL in 1 BOTTLEGEL402
77331-001-05NO-WASH ANTIBACTERIAL50 mL in 1 BOTTLEGEL502
77331-001-06NO-WASH ANTIBACTERIAL60 mL in 1 BOTTLEGEL602
77331-001-07NO-WASH ANTIBACTERIAL80 mL in 1 BOTTLEGEL802
77331-001-08NO-WASH ANTIBACTERIAL100 mL in 1 BOTTLEGEL1002
77331-001-09NO-WASH ANTIBACTERIAL120 mL in 1 BOTTLEGEL1202
77331-001-10NO-WASH ANTIBACTERIAL250 mL in 1 BOTTLEGEL2502
77331-001-11NO-WASH ANTIBACTERIAL300 mL in 1 BOTTLEGEL3002
77331-001-12NO-WASH ANTIBACTERIAL1000 mL in 1 BOTTLEGEL10002
77331-001-13NO-WASH ANTIBACTERIAL2000 mL in 1 BOTTLEGEL20002
77331-001-14NO-WASH ANTIBACTERIAL5000 mL in 1 BOTTLEGEL50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77331-001NO-WASH ANTIBACTERIAL (ETHANOL) GEL [MAJESTIC GROUP LLC]2Legacy NDC, 14 package rows20200513_c47ddba9-9356-4225-a28b-69c5095006b4.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77331-00177331-001-01, 77331-001-02, 77331-001-03, 77331-001-04, 77331-001-05, 77331-001-06, 77331-001-07, 77331-001-08, 77331-001-09, 77331-001-10, 77331-001-11, 77331-001-12, 77331-001-13, 77331-001-14

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
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT

Source Document#

Source XML · Source PDF

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
63484d1d-53c2-46c4-b9fe-9dd23ccdbdb5c47ddba9-9356-4225-a28b-69c5095006b42020-05-11WarningsExact identifier
spl id: 63484d1d-53c2-46c4-b9fe-9dd23ccdbdb5
spl set id: c47ddba9-9356-4225-a28b-69c5095006b4

Reported adverse events (FAERS/openFDA)#

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