FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
SanitizeNow Inc.
Effective date
2020-06-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:18:05

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
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 below 43C Avoid extreme temperatures above 100C (212F)

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:

Benzalkonium Chloride 0.26%
Propylene Glycol
Cocamidolpropyl PG-Dimonium Chloride Phospate
Sterile distilled water or boiled cold water.
Triethylene Glycol
Polysorbate 20
FD&C Blue No. 1
FD&C Yellow No. 5
Xanthan Gum
Aloe Vera Leaf
Lemon
Fragrance

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

Benzalkonium chloride 0.26% 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.

Do not use

OTC - DO NOT USE SECTION

  • In children less than 2 months of age
  • On open skin wounds
  • In eyes. In case of contact, rinse eyes thoroughly with water

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 below 43C
Avoid extreme temperatures above 100C (212F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Cocamidolpropyl PG-Dimonium Chloride Phospate, Triethylene Glycol, Polysorbate 20, FD&C Blue No. 1, FD&C Yellow No. 5, Xanthan Gum, Aloe Vera Leaf, Lemon, Fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 mL NDC: 74988-114-20 2 oz2 oz

118 mL NDC: 74988-114-40 4 oz4 oz
236 mL NDC: 74988-114-80 8 oz8 oz

473 mL NDC: 74988-114-16 16 oz16 oz

3.79 L NDC: 74988-114-37 1 Gal1 Gal

208 L NDC: 74988-114-55 55 Gal55 Gal

1041 L NDC: 74988-114-41 275 gal275 gal

25741 L NDC: 74988-114-74 TankerTanker

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74988-114-162022-01-28C16284748780-1d6a99b39-7487-a426-e053-dadaa90af4c2a61c2fc1-6150-b616-e053-2a95a90a8e72
74988-114-202022-01-28C16284748780-1d6a99b39-7487-a426-e053-dadaa90af4c2a61c2fc1-6150-b616-e053-2a95a90a8e72
74988-114-372022-01-28C16284748780-1d6a99b39-7487-a426-e053-dadaa90af4c2a61c2fc1-6150-b616-e053-2a95a90a8e72
74988-114-402022-01-28C16284748780-1d6a99b39-7487-a426-e053-dadaa90af4c2a61c2fc1-6150-b616-e053-2a95a90a8e72
74988-114-412022-01-28C16284748780-1d6a99b39-7487-a426-e053-dadaa90af4c2a61c2fc1-6150-b616-e053-2a95a90a8e72
74988-114-552022-01-28C16284748780-1d6a99b39-7487-a426-e053-dadaa90af4c2a61c2fc1-6150-b616-e053-2a95a90a8e72
74988-114-742022-01-28C16284748780-1d6a99b39-7487-a426-e053-dadaa90af4c2a61c2fc1-6150-b616-e053-2a95a90a8e72
74988-114-802022-01-28C16284748780-1d6a99b39-7487-a426-e053-dadaa90af4c2a61c2fc1-6150-b616-e053-2a95a90a8e72

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74988-114-16Hand Sanitizer473 mL in 1 BOTTLEGEL4733
74988-114-20Hand Sanitizer59 mL in 1 BOTTLEGEL593
74988-114-37Hand Sanitizer3790 mL in 1 JUGGEL37903
74988-114-40Hand Sanitizer118 mL in 1 BOTTLEGEL1183
74988-114-41Hand Sanitizer1041000 mL in 1 TANKGEL10410003
74988-114-55Hand Sanitizer208000 mL in 1 DRUMGEL2080003
74988-114-74Hand Sanitizer25741000 mL in 1 CONTAINERGEL257410003
74988-114-80Hand Sanitizer236 mL in 1 BOTTLEGEL2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74988-114HAND SANITIZER (ALCOHOL-FREE) GEL [SANITIZENOW INC.]3Legacy NDC, 8 package rows20200618_a61c2fc1-6150-b616-e053-2a95a90a8e72.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74988-11474988-114-20, 74988-114-80, 74988-114-40, 74988-114-37, 74988-114-16, 74988-114-55, 74988-114-41, 74988-114-74

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TRIETHYLENE GLYCOL3P5SU53360IACT
POLYSORBATE 207T1F30V5YHIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
XANTHAN GUMTTV12P4NEEIACT
LEMON24RS0A988OIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
a84e7f79-77fa-56a3-e053-2995a90a672aa61c2fc1-6150-b616-e053-2a95a90a8e722020-06-17WarningsExact identifier
spl id: a84e7f79-77fa-56a3-e053-2995a90a672a
spl set id: a61c2fc1-6150-b616-e053-2a95a90a8e72

Reported adverse events (FAERS/openFDA)#

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