FDA.reportPublic FDA data

Hand Sanitizer Responsible

Manufacturer
SanitizeNow Inc.
Effective date
2021-01-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:36:34

Label at a glance#

ProductHand Sanitizer Responsible
Active ingredientISOPROPYL ALCOHOL
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:

Isopropyl Alcohol (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
Isopropyl Myristate 0% to < 0.25%
Propylene Glycol
Carbomer and/or acrylates/alkyl polymers
Aloe Arborescens Leaf
Tocopheryl Acetate
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

Isopropyl Alcohol 70% 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, Carbomer and/or Crosspolymers, Isopropyl Myristate 0% to < 0.25%, Propylene Glycol, Aloe Arborescens Leaf and/or Tocopheryl Acetate, Fragrance.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 mL NDC: 74988-738-20 2 oz2 oz
118 mL NDC: 74988-738-40 4 oz4 oz
236 mL NDC: 74988-738-80 8 oz8 oz
473 mL NDC: 74988-738-16 16 oz16 oz

946 mL NDC: 74988-738-94 32 oz32 oz

3.78 L NDC: 74988-738-37 1 gal1 gal
1041 L NDC: 74988-738-41 totetote

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581698isopropyl alcohol 70 % Topical GelPSN5
581698isopropyl alcohol 0.7 ML/ML Topical GelSCD5
581698isopropyl alcohol 70 % Topical GelSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130374988738201GTIN-13: 0374988738201
EAN-13: 0374988738201
GTIN-12: 374988738201
UPC-A: 374988738201
GTIN storage (14 digits): 00374988738201		IPA Responsible 2 oz.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74988-738-162022-07-29C16284748780-1e4f33bdf-a01d-d8a0-e053-dadaa90a6e4eaa71b400-32e3-7016-e053-2a95a90af4b8
74988-738-202022-07-29C16284748780-1e4f33bdf-a01d-d8a0-e053-dadaa90a6e4eaa71b400-32e3-7016-e053-2a95a90af4b8
74988-738-372022-07-29C16284748780-1e4f33bdf-a01d-d8a0-e053-dadaa90a6e4eaa71b400-32e3-7016-e053-2a95a90af4b8
74988-738-402022-07-29C16284748780-1e4f33bdf-a01d-d8a0-e053-dadaa90a6e4eaa71b400-32e3-7016-e053-2a95a90af4b8
74988-738-412022-07-29C16284748780-1e4f33bdf-a01d-d8a0-e053-dadaa90a6e4eaa71b400-32e3-7016-e053-2a95a90af4b8
74988-738-802022-07-29C16284748780-1e4f33bdf-a01d-d8a0-e053-dadaa90a6e4eaa71b400-32e3-7016-e053-2a95a90af4b8
74988-738-942022-07-29C16284748780-1e4f33bdf-a01d-d8a0-e053-dadaa90a6e4eaa71b400-32e3-7016-e053-2a95a90af4b8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74988-738-16Hand Sanitizer Responsible473 mL in 1 BOTTLEGEL4735
74988-738-20Hand Sanitizer Responsible59 mL in 1 BOTTLEGEL595
74988-738-37Hand Sanitizer Responsible3780 mL in 1 JUGGEL37805
74988-738-40Hand Sanitizer Responsible118 mL in 1 BOTTLEGEL1185
74988-738-41Hand Sanitizer Responsible1041000 mL in 1 TANKGEL10410005
74988-738-80Hand Sanitizer Responsible236 mL in 1 BOTTLEGEL2365
74988-738-94Hand Sanitizer Responsible946 mL in 1 BOTTLEGEL9465

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74988-738HAND SANITIZER RESPONSIBLE (ISOPROPYL ALCOHOL RESPONSIBLE) GEL [SANITIZENOW INC.]5Legacy NDC, 7 package rows20210107_aa71b400-32e3-7016-e053-2a95a90af4b8.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74988-73874988-738-20, 74988-738-40, 74988-738-80, 74988-738-16, 74988-738-37, 74988-738-41, 74988-738-94

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE ARBORESCENS LEAF09TD8L5SQVIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
b83f9343-1e5f-5653-e053-2a95a90a02f2aa71b400-32e3-7016-e053-2a95a90af4b82021-01-06WarningsExact identifier
spl id: b83f9343-1e5f-5653-e053-2a95a90a02f2
spl set id: aa71b400-32e3-7016-e053-2a95a90af4b8

Reported adverse events (FAERS/openFDA)#

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