FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Saje Natural Business Inc.
Effective date
2026-01-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:32:56

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Spray 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

Alcohol 68% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Product Identity

DESCRIPTION SECTION

Hand Sanitizer - Antibacterial Spray

2 fl oz | 60 ml

3.4 fl oz | 100 ml
6.8 fl oz | 200 ml
33.8 fl oz | 1 L

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. If contact occurs with eyes, rinse 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, contact a Poison Control Center right away or get medical help 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

  • Spray 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

aloe barbadensis leaf juice powder, glycerin, lime oil, purified water.

Hand Sanitizer Spray - Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 70983-025-04

HandSantizer_60mlHandSantizer_60ml

100 mL NDC: 70983-025-01 Saje 100 ml Hand SanitizerSaje 100 ml Hand Sanitizer

200 mL NDC: 70983-025-02 Saje 200 ml Hand SanitzerSaje 200 ml Hand Sanitzer

1 L NDC: 70983-025-03 Saje 1L Hand SanitizerSaje 1L Hand Sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1812262ethanol 68 % Topical SprayPSN6
1812262ethanol 0.68 ML/ML Topical SpraySCD6
1812262ethanol 68 % Topical SpraySY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-025-01Hand Sanitizer100 mL in 1 BOTTLE, SPRAYSPRAY1006
70983-025-02Hand Sanitizer200 mL in 1 BOTTLE, SPRAYSPRAY2006
70983-025-03Hand Sanitizer1000 mL in 1 BOTTLE, SPRAYSPRAY10006
70983-025-04Hand Sanitizer60 mL in 1 BOTTLE, SPRAYSPRAY606

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
70983-02570983-025-01, 70983-025-02, 70983-025-03, 70983-025-04

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
LIME OILUZH29XGA8GIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
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
Hand SanitizerALCOHOLSaje Natural Business Inc.a70da1c6-4ca6-b801-e053-2a95a90ae1a52026-01-13WarningsExact identifier
ndc (package): 70983-025-01
ndc (package): 70983-025-02
ndc (package): 70983-025-04
ndc (package): 70983-025-03
ndc (product): 70983-025
ndc11 (package): 70983002501
ndc11 (package): 70983002502
ndc11 (package): 70983002504
ndc11 (package): 70983002503
spl id: 484f5b98-83f8-74b5-e063-6294a90a8019
spl set id: a70da1c6-4ca6-b801-e053-2a95a90ae1a5

Reported adverse events (FAERS/openFDA)#

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