FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Singtech Inc.
Effective date
2021-01-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:37:08

Label at a glance#

ProductHand Sanitizer
Active ingredientHYDROGEN PEROXIDE, ALCOHOL
Label structure16 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Hydrogen Peroxide 4% Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

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

water, glycerin, natural and artificial fragrances.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75334-034-03
PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75334-031-03
PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75334-032-03
PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75334-033-03
Principal Display PanelPrincipal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75334-025-03
PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2384136ethanol 70 % / hydrogen peroxide 4 % Topical SprayPSN5
1041849ethanol 70 % Topical SprayPSN5
2384136ethanol 0.7 ML/ML / hydrogen peroxide 40 ML/ML Topical SpraySCD5
1041849ethanol 0.7 ML/ML Topical SpraySCD5
2384136ethanol 70 % / hydrogen peroxide 4 % Topical SpraySY5
1041849ethanol 70 % Topical SpraySY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75334-031-032022-07-29C16284748780-1e4f33bdf-adc5-d8a0-e053-dadaa90a6e4e100%Klean Hand Sanitizers Scented
75334-032-032022-07-29C16284748780-1e4f33bdf-adc5-d8a0-e053-dadaa90a6e4e100%Klean Hand Sanitizers Scented
75334-033-032022-07-29C16284748780-1e4f33bdf-adc5-d8a0-e053-dadaa90a6e4e100%Klean Hand Sanitizers Scented
75334-034-032022-07-29C16284748780-1e4f33bdf-adc5-d8a0-e053-dadaa90a6e4e100%Klean Hand Sanitizers Scented
75334-035-032022-07-29C16284748780-1e4f33bdf-adc5-d8a0-e053-dadaa90a6e4e100%Klean Hand Sanitizers Scented

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75334-031-03Hand Sanitizer119 mL in 1 BOTTLE, PUMPAEROSOL, SPRAY1195
75334-032-03Hand Sanitizer119 mL in 1 BOTTLE, PUMPAEROSOL, SPRAY1195
75334-033-03Hand Sanitizer119 mL in 1 BOTTLE, PUMPAEROSOL, SPRAY1195
75334-034-03Hand Sanitizer119 mL in 1 BOTTLE, PUMPAEROSOL, SPRAY1195
75334-035-03Hand Sanitizer119 mL in 1 BOTTLE, PUMPAEROSOL, SPRAY1195

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75334-031HAND SANITIZER (ETHYL ALCOHOL) AEROSOL, SPRAY [SINGTECH INC.]5Legacy NDC, 1 package rows20210121_a9f537cc-a82b-7aa0-e053-2a95a90a0974.zip
75334-032HAND SANITIZER (ETHYL ALCOHOL) AEROSOL, SPRAY [SINGTECH INC.]5Legacy NDC, 1 package rows20210121_a9f537cc-a82b-7aa0-e053-2a95a90a0974.zip
75334-033HAND SANITIZER (ETHYL ALCOHOL) AEROSOL, SPRAY [SINGTECH INC.]5Legacy NDC, 1 package rows20210121_a9f537cc-a82b-7aa0-e053-2a95a90a0974.zip
75334-034HAND SANITIZER (ETHYL ALCOHOL) AEROSOL, SPRAY [SINGTECH INC.]5Legacy NDC, 1 package rows20210121_a9f537cc-a82b-7aa0-e053-2a95a90a0974.zip
75334-035HAND SANITIZER (ETHYL ALCOHOL) AEROSOL, SPRAY [SINGTECH INC.]5Legacy NDC, 1 package rows20210121_a9f537cc-a82b-7aa0-e053-2a95a90a0974.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75334-03175334-031-03
75334-03275334-032-03
75334-03375334-033-03
75334-03475334-034-03
75334-03575334-035-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEPPERMINTV95R5KMY2BIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
VACCINIUM MYRTILLUS ANTHOCYANOSIDESR911H793SUIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB
ALCOHOL3K9958V90MACTIB
VANILLAQ74T35078HIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB
ALCOHOL3K9958V90MACTIB
VANILLINCHI530446XIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
PEPPERMINTV95R5KMY2BIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
COCONUT OILQ9L0O73W7LIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ORANGE OIL TERPENELESSL8B7EWV9I7IACT
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
b95bb524-6eca-25b1-e053-2995a90a3309a9f537cc-a82b-7aa0-e053-2a95a90a09742021-01-20WarningsExact identifier
spl id: b95bb524-6eca-25b1-e053-2995a90a3309
spl set id: a9f537cc-a82b-7aa0-e053-2a95a90a0974

Reported adverse events (FAERS/openFDA)#

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