FDA.reportPublic FDA data

CVS PHARMACY

Manufacturer
CVS PHARMACY | APOLLO HEALTH AND BEAUTY CARE INC.
Effective date
2020-03-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:04:03

Label at a glance#

ProductCVS PHARMACY REFRESHING
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

helps eliminate bacteria on hands.

Dosage and administration

apply onto wet hands. lather and rinse thoroughly.

Storage and handling

store at room temperature.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

  • helps eliminate bacteria on hands.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation or redness develops and lasts.
Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply onto wet hands.
  • lather and rinse thoroughly.

Other information

STORAGE AND HANDLING SECTION

store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200).

Label copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of the labelimage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN5
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD5
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY5
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-325-562022-01-28C16284748780-19d75b9d0-c856-f424-e053-dadaa90a57ceDRUG FACTS
59779-325-562020-03-18C16284748780-19d75b9d0-c856-f424-e053-dadaa90a57ceDRUG FACTS
59779-325-562020-01-31C16284748780-19d75b9d0-c856-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-325-56CVS PHARMACYREFRESHING1656 mL in 1 BOTTLE, PLASTICLIQUID16565

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-325CVS PHARMACY REFRESHING (BENZALKONIUM CHLORIDE) LIQUID [CVS PHARMACY]5Legacy NDC, 1 package rows20200319_b783588f-0f0d-4446-bd78-1f23c7116199.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-32559779-325-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
GLYCERINPDC6A3C0OXIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
COCO MONOETHANOLAMIDEC80684146DIACT
SODIUM CHLORIDE451W47IQ8XIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM SULFATE0YPR65R21JIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 339DBA0SBB0LIACT

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
ce9f0206-a283-47db-9d2f-4bea3a8f183fb783588f-0f0d-4446-bd78-1f23c71161992020-03-18WarningsExact identifier
spl id: ce9f0206-a283-47db-9d2f-4bea3a8f183f
spl set id: b783588f-0f0d-4446-bd78-1f23c7116199

Reported adverse events (FAERS/openFDA)#

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