Hand Sanitizer

Manufacturer
SanitizeNow Inc.
Effective date
2021-01-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:36:34

Label at a glance#

ProductHand 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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product:

Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Sterile distilled water or boiled cold water.
Hydrogen Peroxide
Glycerin

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% 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

Water, Hydrogen Peroxide, Glycerin.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 mL NDC: 74988-737-20 2oz2oz
118 mL NDC: 74988-737-40 4oz4oz
236 mL NDC: 74988-737-80 8oz8oz
473 mL NDC: 74988-737-16 16oz16oz
3.78 L NDC: 74988-737-37 galgal

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN3
1039339ethanol 0.8 ML/ML Topical SolutionSCD3
1039339ethanol 80 % Topical SolutionSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130374988737167GTIN-13: 0374988737167
EAN-13: 0374988737167
GTIN-12: 374988737167
UPC-A: 374988737167
GTIN storage (14 digits): 00374988737167
Updated_80__Responsible-16oz-Label.jpg
BarcodeEAN-130374988737372GTIN-13: 0374988737372
EAN-13: 0374988737372
GTIN-12: 374988737372
UPC-A: 374988737372
GTIN storage (14 digits): 00374988737372
Updated_80__Responsible_1gallon_label.jpg
BarcodeEAN-130374988737402GTIN-13: 0374988737402
EAN-13: 0374988737402
GTIN-12: 374988737402
UPC-A: 374988737402
GTIN storage (14 digits): 00374988737402
Updated_80__Responsible_4oz_label.jpg
BarcodeEAN-130374988737808GTIN-13: 0374988737808
EAN-13: 0374988737808
GTIN-12: 374988737808
UPC-A: 374988737808
GTIN storage (14 digits): 00374988737808
Updated_80__Responsible-8oz-Label.jpg

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74988-737-16Hand Sanitizer473 mL in 1 BOTTLELIQUID4733
74988-737-20Hand Sanitizer59 mL in 1 BOTTLELIQUID593
74988-737-37Hand Sanitizer3780 mL in 1 JUGLIQUID37803
74988-737-40Hand Sanitizer118 mL in 1 BOTTLELIQUID1183
74988-737-80Hand Sanitizer236 mL in 1 BOTTLELIQUID2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74988-737HAND SANITIZER (ALCOHOL) LIQUID [SANITIZENOW INC.]3Legacy NDC, 5 package rows20210107_a8ffb2dd-e8a3-de7a-e053-2995a90a33b3.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
74988-73774988-737-20, 74988-737-40, 74988-737-80, 74988-737-16, 74988-737-37

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
b83f8136-b003-77ac-e053-2995a90a2bb5a8ffb2dd-e8a3-de7a-e053-2995a90a33b32021-01-06WarningsExact identifier
spl id: b83f8136-b003-77ac-e053-2995a90a2bb5
spl set id: a8ffb2dd-e8a3-de7a-e053-2995a90a33b3

Reported adverse events (FAERS/openFDA)#

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