FDA.reportPublic FDA data

SANIPOWER Hand Sanitizer

Manufacturer
IVERO d.o.o.
Effective date
2020-09-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:02

Label at a glance#

ProductSANIPOWER Hand Sanitizer
Active ingredientALCOHOL, ISOPROPYL ALCOHOL, BENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

Apply 3-5mL (approx. 1 tsp) of product to dry hands and wrists and rub until dry (at least 30 seconds). Period required for biocidal effect: 30-60 seconds. For external use only. Supervise children under 6 years of age when using product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 15%

Ethyl Alcohol 55%

Benzalkonium chloride 0.0165%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

To reduce harmful bacteria on skin.

Directions For Use

DOSAGE & ADMINISTRATION SECTION

  • Apply 3-5mL (approx. 1 tsp) of product to dry hands and wrists and rub until dry (at least 30 seconds). Period required for biocidal effect: 30-60 seconds.
  • For external use only.
  • Supervise children under 6 years of age when using product to avoid swallowing.

Hazard Statements

WARNINGS SECTION

  • Causes serious eye irritation. Highly flammable liquid and vapor. May cause drowsiness or dizziness.

Precautionary Statements

OTC - DO NOT USE SECTION

  • Keep out of reach of children.
  • Do not use on children less than 2 months of age.
  • Do not use on open skin wounds.
  • If in eyes, rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do; continue rinsing. If eye irritation persists, get medical advice/attention.
  • Avoid breathing dust/fumes/gas/mist/vapors/aerosol.
  • Keep away from heat, hot areas, sparks, open flames and other sources of ignition such as smoking.
  • Store in a well-ventilated place between 15-30°C (59-86°F). Keep container tightly closed. Dispose of contents/container in accordance with national regulations.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Note

OTC - WHEN USING SECTION

Read accompanying leaflet before use. Call Poison Control if you feel unwell after use - (800) 222-1222. For additional information, see safety data sheet.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

non-ionic surfactants, glycerin

Hazard Pictogram

WARNINGS AND PRECAUTIONS SECTION

ExclamationExclamationFireFire

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SANIPOWER 1000mLSANIPOWER 1000mL1000mL NDC: 80133-003-10

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2396264benzalkonium chloride 0.0165 % / ethanol 55 % / isopropyl alcohol 15 % Topical GelPSN1
2396264benzalkonium chloride 0.000165 MG/MG / ethanol 0.55 ML/ML / isopropyl alcohol 0.15 ML/ML Topical GelSCD1
2396264benzalkonium chloride 0.0165 % / ethanol 55 % / isopropyl alcohol 15 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80133-003-102022-01-28C16284748780-1d6a99b39-7b3c-a426-e053-dadaa90af4c2aed96951-210d-89ed-e053-2995a90ac8c0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80133-003-10SANIPOWER Hand Sanitizer1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80133-003SANIPOWER HAND SANITIZER (HAND SANITIZER) GEL [IVERO D.O.O.]1Legacy NDC, 1 package rows20200911_aed96951-210d-89ed-e053-2995a90ac8c0.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
80133-00380133-003-10

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
ALCOHOL3K9958V90MACTIB
ISOPROPYL ALCOHOLND2M416302ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
aed96951-210e-89ed-e053-2995a90ac8c0aed96951-210d-89ed-e053-2995a90ac8c02020-09-09WarningsExact identifier
spl id: aed96951-210e-89ed-e053-2995a90ac8c0
spl set id: aed96951-210d-89ed-e053-2995a90ac8c0

Reported adverse events (FAERS/openFDA)#

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