FDA.reportPublic FDA data

CVS Foaming Hand Sanitizer

Manufacturer
CVS Health | Garcoa, Inc.
Effective date
2022-01-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:39

Label at a glance#

ProductCVS Foaming Hand Sanitizer Antibacterial
Active ingredientBenzalkonium Chloride
Label structure9 sections

Indications and uses

♦ hand sanitizer to help reduce bacteria on the skin that could cause disease ♦ Recommended for repeated use

Dosage and administration

♦ place enough product in your palm to thoroughly cover your hands ♦ rub hands together briskly until dry ♦ children under 6 years of age should be supervised when using this product

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

  • hand sanitizer to help reduce bacteria on the skin that could cause disease
  • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts

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 in your palm to thoroughly cover your hands
  • rub hands together briskly until dry
  • children under 6 years of age should be supervised when using this product

Other information

SPL UNCLASSIFIED SECTION

  • To prevent discoloration, avoid contact with clothing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetrimonium Chloride, Citric Acid, Cocamidopropylamine Oxide, Cocamidopropyl Betaine, Glycerin, Propylene Glycol, Water.

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 222 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

♥CVS
Health™

Foaming
Hand
Sanitizer

INSTANT

  • Antibacterial
  • Alcohol free

KILLS
99.99%
OF GERMS*

Unscented

7.5 FL OZ (222 mL)

*Effective at eliminating more than 99.99%
or many common harmful germs and
bacteria in as little as 15 seconds.

05-3201
L0015035FB

PRINCIPAL DISPLAY PANEL - 222 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 222 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN2
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD2
1020365benzalkonium chloride 0.13 % Topical FoamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-584-012025-01-30C16284748780-12cef2736-a6e7-d83d-e063-dadaa90ab31fCVS Foaming Hand Sanitizer Antibacterial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-584-01CVS Foaming Hand Sanitizer Antibacterial222 mL in 1 BOTTLE, DISPENSINGLIQUID2222

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-584CVS FOAMING HAND SANITIZER ANTIBACTERIAL (BENZALKONIUM CHLORIDE) LIQUID [CVS HEALTH]2Legacy NDC, 1 package rows20220127_90ad0d77-cc40-46f2-99ac-2d358aee6d01.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-58469842-584-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzalkonium ChlorideF5UM2KM3W7ACTIB
Cetrimonium ChlorideUC9PE95IBPIACT
Citric Acid Monohydrate2968PHW8QPIACT
Cocamidopropylamine OxideM4SL82J7HKIACT
Cocamidopropyl Betaine5OCF3O11KXIACT
GlycerinPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
Water059QF0KO0RIACT

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
90febb8c-1c79-4260-bbc7-39e2a4c2e9c390ad0d77-cc40-46f2-99ac-2d358aee6d012022-01-25WarningsExact identifier
spl id: 90febb8c-1c79-4260-bbc7-39e2a4c2e9c3
spl set id: 90ad0d77-cc40-46f2-99ac-2d358aee6d01

Reported adverse events (FAERS/openFDA)#

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