FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
SUN WAVE WELLNESS, LLC
Effective date
2020-08-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:25:53

Label at a glance#

ProductHAND SANITIZER
Active ingredientISOPROPYL ALCOHOL
Label structure9 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.

Label contents#

Full prescribing information#

Use(s)

INDICATIONS & USAGE SECTION

To help reduce bacteria on the skin. For use when soap and water are not available.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

  • on children less than 2 months of age
  • on open skin wounds
  • around eyes
  • in ears and mouth

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth.

Incase of contact with eyes, rinse eyes thoroughly with water.

  • avoid contact with broken skin
  • do not inhale or ingest

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or rash occurs.

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.

Purpose

OTC - PURPOSE SECTION

Antiseptic

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

OTHER SAFETY INFORMATION

  • Store between 15-30C (59-86F)
  • Avoid freezing and exessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadenisis (leaf) Extract, Fragrance, Glycerin, Purified Water

Manufactured by:

HOW SUPPLIED SECTION

Sun Wave Wellness, LLC

1419 Chaffee Drive #101

Titusville, FL 32780-7933

sunwavesanitizer.com

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100mL label spray variant100mL label spray variant

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75023-002-012022-01-28C16284748780-1d6a99b39-e173-a426-e053-dadaa90af4c2VERSION 2: CORRECTION CORRECTION: (1) LABEL IMAGE CORRECTION CONSUMER HAND SANITIZER; NON-EMERGENCY; ISOPROPYL ALCHOL (IPA) = DEFERRED GRASE ACTIVE INGREDIENT DETERMINATION EFFECTIVE APRIL 13, 2020; PART333E FOR OTC HAND RUB SANTIZERS (CONSUMER)
75023-002-022022-01-28C16284748780-1d6a99b39-e173-a426-e053-dadaa90af4c2VERSION 2: CORRECTION CORRECTION: (1) LABEL IMAGE CORRECTION CONSUMER HAND SANITIZER; NON-EMERGENCY; ISOPROPYL ALCHOL (IPA) = DEFERRED GRASE ACTIVE INGREDIENT DETERMINATION EFFECTIVE APRIL 13, 2020; PART333E FOR OTC HAND RUB SANTIZERS (CONSUMER)
75023-002-032022-01-28C16284748780-1d6a99b39-e173-a426-e053-dadaa90af4c2VERSION 2: CORRECTION CORRECTION: (1) LABEL IMAGE CORRECTION CONSUMER HAND SANITIZER; NON-EMERGENCY; ISOPROPYL ALCHOL (IPA) = DEFERRED GRASE ACTIVE INGREDIENT DETERMINATION EFFECTIVE APRIL 13, 2020; PART333E FOR OTC HAND RUB SANTIZERS (CONSUMER)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75023-002-01HAND SANITIZER100 mL in 1 BOTTLE, SPRAYLIQUID1002
75023-002-02HAND SANITIZER100 mL in 1 BOTTLE, DISPENSINGLIQUID1002
75023-002-03HAND SANITIZER100 mL in 1 BOTTLE, WITH APPLICATORLIQUID1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75023-002HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [SUN WAVE WELLNESS, LLC]2Legacy NDC, 3 package rows20200827_a9b5edf7-6837-ba04-e053-2995a90ac3e6.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
75023-00275023-002-01, 75023-002-02, 75023-002-03

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
ISOPROPYL ALCOHOLND2M416302ACTIB
LIMONENE, (+)-GFD7C86Q1WIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
adcaed72-cd03-82d0-e053-2995a90a6d11a9b5edf7-6837-ba04-e053-2995a90ac3e62020-08-26WarningsExact identifier
spl id: adcaed72-cd03-82d0-e053-2995a90a6d11
spl set id: a9b5edf7-6837-ba04-e053-2995a90ac3e6

Reported adverse events (FAERS/openFDA)#

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