FDA.reportPublic FDA data

Antimicrobial Hand Sanitizer

Manufacturer
NVIP LLC
Effective date
2020-08-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:24

Label at a glance#

ProductAntimicrobial Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly together until dry. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use[s]

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For External use only.

Do not use

OTC - DO NOT USE SECTION

  • on children less than 2 months of age
  • on open skin wounds

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash appears and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover your hands.
  • Rub hands together briskly together until dry.
  • Children under 6 years of age should be supervised when using this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Isopropyl Alcohol, PEG-12 Dimethicone, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate.

Other information

SPL UNCLASSIFIED SECTION

  • Store between 54-84°F (15-30°C)
  • May discolor certain fabrics or surfaces

80182-001-12

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

80182-001-16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76939-555-122022-01-28C16284748780-1d6a99b39-c6ef-a426-e053-dadaa90af4c2Antimicrobial Hand Sanitizer
76939-555-162022-01-28C16284748780-1d6a99b39-c6ef-a426-e053-dadaa90af4c2Antimicrobial Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76939-555-12Antimicrobial Hand Sanitizer350 mL in 1 BOTTLEGEL3501
76939-555-16Antimicrobial Hand Sanitizer475 mL in 1 BOTTLEGEL4751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76939-555ANTIMICROBIAL HAND SANITIZER (ALCOHOL) GEL [NVIP LLC]1Legacy NDC, 2 package rows20200821_ad545737-d113-3d94-e053-2995a90adeee.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
76939-55576939-555-12, 76939-555-16

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
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
PEG-12 DIMETHICONEZEL54N6W95IACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB

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
ad543603-1b74-8d1c-e053-2a95a90a830ead545737-d113-3d94-e053-2995a90adeee2020-08-20WarningsExact identifier
spl id: ad543603-1b74-8d1c-e053-2a95a90a830e
spl set id: ad545737-d113-3d94-e053-2995a90adeee

Reported adverse events (FAERS/openFDA)#

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