FDA.reportPublic FDA data

Care & Co Hand Sanitizer Gel

Manufacturer
CARE AND COMPANY USA. LLC
Effective date
2021-02-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:45

Label at a glance#

ProductCare and Co Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping.

Other information

SPL UNCLASSIFIED SECTION

  • Store between 59-86°F (15-30°C)
  • Avoid freezing and excessive heat above 104°F (40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, hydroxyethyl cellulose, reverse osmosis water.

Questions or Comments?

OTC - QUESTIONS SECTION

(866) 322-7326

Package Labeling:59ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Package Labeling:237ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label2label2

Package Labeling:500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label3label3

Package Labeling:1L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label4label4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098199benzalkonium chloride 0.13 % Topical GelPSN2
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCD2
1098199benzalkonium chloride 0.13 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80755-000-012023-01-30C16284748780-1f386c64a-16ec-0266-e053-dadaa90a7c1aCare & Co Hand Sanitizer Gel
80755-000-022023-01-30C16284748780-1f386c64a-16ec-0266-e053-dadaa90a7c1aCare & Co Hand Sanitizer Gel
80755-000-032023-01-30C16284748780-1f386c64a-16ec-0266-e053-dadaa90a7c1aCare & Co Hand Sanitizer Gel
80755-000-042023-01-30C16284748780-1f386c64a-16ec-0266-e053-dadaa90a7c1aCare & Co Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80755-000-01Care and Co Hand Sanitizer59 mL in 1 BOTTLEGEL592
80755-000-02Care and Co Hand Sanitizer237 mL in 1 BOTTLEGEL2372
80755-000-03Care and Co Hand Sanitizer500 mL in 1 BOTTLEGEL5002
80755-000-04Care and Co Hand Sanitizer1000 mL in 1 BOTTLEGEL10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80755-000CARE AND CO HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [CARE AND COMPANY USA. LLC]2Legacy NDC, 4 package rows20210204_b8ba7ebc-95c1-4b24-e053-2995a90a09cb.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80755-00080755-000-01, 80755-000-02, 80755-000-03, 80755-000-04

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
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERINPDC6A3C0OXIACT

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
ba721a16-7224-75eb-e053-2a95a90af9bfb8ba7ebc-95c1-4b24-e053-2995a90a09cb2021-02-03WarningsExact identifier
spl id: ba721a16-7224-75eb-e053-2a95a90af9bf
spl set id: b8ba7ebc-95c1-4b24-e053-2995a90a09cb

Reported adverse events (FAERS/openFDA)#

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