FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
SanitizeNow Inc.
Effective date
2020-11-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:32:48

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:

Ethyl Alcohol 80% (70%, 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

18.95 L NDC: 74988-720-95 5 gal5 gal

29 mL NDC: 74988-720-10 29 ml29 ml59 mL NDC: 74988-720-20 59 ml59 ml118 mL NDC: 74988-720-40 118 ml118 ml236 mL NDC: 74988-720-80 236 ml 1236 ml 1236 mL NDC: 74988-720-81 236 ml 2236 ml 2 236 mL NDC: 74988-720-82 236 ml 3236 ml 3473 mL NDC: 74988-720-16 473 ml473 ml650 mL NDC: 74988-720-22 650 ml650 ml1 L NDC: 74988-720-11 1 Liter1 Liter

3.79 L NDC: 74988-720-37 3.79 L3.79 L208 L NDC: 74988-720-55 208 L208 L

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74988-720-102022-01-28C16284748780-1d6a99b39-9758-a426-e053-dadaa90af4c2a3fb4b39-72c4-c3c7-e053-2a95a90a6e35
74988-720-112022-01-28C16284748780-1d6a99b39-9758-a426-e053-dadaa90af4c2a3fb4b39-72c4-c3c7-e053-2a95a90a6e35
74988-720-162022-01-28C16284748780-1d6a99b39-9758-a426-e053-dadaa90af4c2a3fb4b39-72c4-c3c7-e053-2a95a90a6e35
74988-720-202022-01-28C16284748780-1d6a99b39-9758-a426-e053-dadaa90af4c2a3fb4b39-72c4-c3c7-e053-2a95a90a6e35
74988-720-222022-01-28C16284748780-1d6a99b39-9758-a426-e053-dadaa90af4c2a3fb4b39-72c4-c3c7-e053-2a95a90a6e35
74988-720-372022-01-28C16284748780-1d6a99b39-9758-a426-e053-dadaa90af4c2a3fb4b39-72c4-c3c7-e053-2a95a90a6e35
74988-720-402022-01-28C16284748780-1d6a99b39-9758-a426-e053-dadaa90af4c2a3fb4b39-72c4-c3c7-e053-2a95a90a6e35
74988-720-552022-01-28C16284748780-1d6a99b39-9758-a426-e053-dadaa90af4c2a3fb4b39-72c4-c3c7-e053-2a95a90a6e35
74988-720-802022-01-28C16284748780-1d6a99b39-9758-a426-e053-dadaa90af4c2a3fb4b39-72c4-c3c7-e053-2a95a90a6e35
74988-720-812022-01-28C16284748780-1d6a99b39-9758-a426-e053-dadaa90af4c2a3fb4b39-72c4-c3c7-e053-2a95a90a6e35
74988-720-822022-01-28C16284748780-1d6a99b39-9758-a426-e053-dadaa90af4c2a3fb4b39-72c4-c3c7-e053-2a95a90a6e35
74988-720-952022-01-28C16284748780-1d6a99b39-9758-a426-e053-dadaa90af4c2a3fb4b39-72c4-c3c7-e053-2a95a90a6e35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74988-720-10Hand Sanitizer29 mL in 1 BOTTLELIQUID292
74988-720-11Hand Sanitizer1000 mL in 1 BOTTLELIQUID10002
74988-720-16Hand Sanitizer473 mL in 1 BOTTLELIQUID4732
74988-720-20Hand Sanitizer59 mL in 1 BOTTLELIQUID592
74988-720-22Hand Sanitizer650 mL in 1 BOTTLELIQUID6502
74988-720-37Hand Sanitizer3790 mL in 1 JUGLIQUID37902
74988-720-40Hand Sanitizer118 mL in 1 BOTTLELIQUID1182
74988-720-55Hand Sanitizer208000 mL in 1 DRUMLIQUID2080002
74988-720-80Hand Sanitizer236 mL in 1 BOTTLELIQUID2362
74988-720-81Hand Sanitizer236 mL in 1 BOTTLE, PUMPLIQUID2362
74988-720-82Hand Sanitizer236 mL in 1 BOTTLE, SPRAYLIQUID2362
74988-720-95Hand Sanitizer18950 mL in 1 BOTTLE, WITH APPLICATORLIQUID189502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74988-720HAND SANITIZER (ALCOHOL) LIQUID [SANITIZENOW INC.]2Legacy NDC, 12 package rows20201104_a3fb4b39-72c4-c3c7-e053-2a95a90a6e35.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
74988-72074988-720-10, 74988-720-20, 74988-720-40, 74988-720-80, 74988-720-81, 74988-720-82, 74988-720-16, 74988-720-22, 74988-720-11, 74988-720-37, 74988-720-55, 74988-720-95

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
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
b338d33c-f01d-e125-e053-2995a90a1a62a3fb4b39-72c4-c3c7-e053-2a95a90a6e352020-11-03WarningsExact identifier
spl id: b338d33c-f01d-e125-e053-2995a90a1a62
spl set id: a3fb4b39-72c4-c3c7-e053-2a95a90a6e35

Reported adverse events (FAERS/openFDA)#

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