FDA.reportPublic FDA data

Aktive Hand Sanitizer

Manufacturer
NVIP LLC
Effective date
2023-02-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:53:46

Label at a glance#

ProductAktive Hand Sanitizer
Active ingredientALCOHOL
Label structure13 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#

SPL UNCLASSIFIED SECTION

This is a gel hand sanitizer manufactured with 70% ethanol as active ingredient according to the FDA monograph.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

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

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

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 ingredients

INACTIVE INGREDIENT SECTION

glycerin, modified polysaccharides, purified water USP, fregrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 mL NDC: 76939-541-05

70% gel Aktive Hand Sanitizer70% gel Aktive Hand Sanitizer

118ml NDC 76939-541-04

4oz Aktive Hand Sanitizer4oz Aktive Hand Sanitizer

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76939-541-042024-07-30C16284748780-11030e365-12a2-111a-e063-dadaa90a10e2Aktive Hand Sanitizer 541
76939-541-052024-07-30C16284748780-11030e365-12a2-111a-e063-dadaa90a10e2Aktive Hand Sanitizer 541
76939-541-042024-01-30C16284748780-11030e365-12a2-111a-e063-dadaa90a10e2Aktive Hand Sanitizer 541
76939-541-052024-01-30C16284748780-11030e365-12a2-111a-e063-dadaa90a10e2Aktive Hand Sanitizer 541

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76939-541-04Aktive Hand Sanitizer118 mL in 1 BOTTLELIQUID1185
76939-541-05Aktive Hand Sanitizer236 mL in 1 BOTTLELIQUID2365

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76939-541AKTIVE HAND SANITIZER (ALCOHOL) LIQUID [NVIP LLC]5Legacy NDC, 2 package rows20230209_a45be076-77f4-463f-e053-2a95a90aa51a.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76939-54176939-541-04, 76939-541-05

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
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
f436f5b6-f2fd-ff6e-e053-2995a90a2f7da45be076-77f4-463f-e053-2a95a90aa51a2023-02-08WarningsExact identifier
spl id: f436f5b6-f2fd-ff6e-e053-2995a90a2f7d
spl set id: a45be076-77f4-463f-e053-2a95a90aa51a

Reported adverse events (FAERS/openFDA)#

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