FDA.reportPublic FDA data

Companion

Manufacturer
Preserve International
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:45:49

Label at a glance#

ProductCompanion
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

For hand washing to minimize bacteria on the skin.

Dosage and administration

Pump foam into dry hands. Lather with water for atleast 20 seconds. Rinse and pat dry. Store below 110°F (43°C).  Water, Xanthan Gum, Glycerin, Sodium Lauryl Eather Sulfate, Alkylpolyglycoside, Cocamidopropyl Betaine, Citric Acid, Sodium Citrate, Tetrasodium Ethylenediamine Tetraacetate, Sodium Benzoate, Waterfall Mist, Blue #1, Yellow #5.

Label contents#

Full prescribing information#

DRUG FACTS Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%....................Antibacterial

PURPOSE

OTC - PURPOSE SECTION

Antimicrobial

USES

INDICATIONS & USAGE SECTION

For hand washing to minimize bacteria on the skin.

WARNINGS

WARNINGS SECTION

For External use only.

When using this product avoid contact with eyes.  In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops.

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

  • Pump foam into dry hands.
  • Lather with water for atleast 20 seconds.
  • Rinse and pat dry.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Store below 110°F (43°C). 

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Xanthan Gum, Glycerin, Sodium Lauryl Eather Sulfate, Alkylpolyglycoside, Cocamidopropyl Betaine, Citric Acid, Sodium Citrate, Tetrasodium Ethylenediamine Tetraacetate, Sodium Benzoate, Waterfall Mist, Blue #1, Yellow #5.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPANION

Foaming Antibacterial Hand Soap

  • Kills 99.9% of common bacteria
  • Moisturizing Formula
  • Light Fresh Scent

NET CONTENTS: 16.9 oz. (750 ml)

Item No.: 4900912/6

​Manufactured By:

Preserve International, a wholly-owned subsidiary of Neogen ®

944 Nandino Blvd. Lexington, KY 40511 USA

800-477-8201 (USA/Canada) or 859-254-1221 L7018-0920

CompanionAntibacterial Hand SoapCompanionAntibacterial Hand Soap

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60648-7200-12023-07-24C16284748780-1d6a99b39-97e7-a426-e053-dadaa90af4c2COMPANION Foaming Antibacterial Hand Soap
60648-7200-22023-07-24C16284748780-1d6a99b39-97e7-a426-e053-dadaa90af4c2COMPANION Foaming Antibacterial Hand Soap
60648-7200-12022-01-28C16284748780-1d6a99b39-97e7-a426-e053-dadaa90af4c2COMPANION Foaming Antibacterial Hand Soap
60648-7200-22022-01-28C16284748780-1d6a99b39-97e7-a426-e053-dadaa90af4c2COMPANION Foaming Antibacterial Hand Soap

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60648-7200COMPANION (COMPANION ANTIBACTERIAL HAND SOAP) LIQUID [PRESERVE INTERNATIONAL]4Legacy NDC20241218_f60ebf07-ba25-45f6-a381-e4d439dab0f9.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60648-720060648-7200-1, 60648-7200-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
EDETATE SODIUMMP1J8420LUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SODIUM BENZOATEOJ245FE5EUIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
296a5d5a-9d2b-fef9-e063-6294a90a1b08f60ebf07-ba25-45f6-a381-e4d439dab0f92024-12-16WarningsExact identifier
spl id: 296a5d5a-9d2b-fef9-e063-6294a90a1b08
spl set id: f60ebf07-ba25-45f6-a381-e4d439dab0f9

Reported adverse events (FAERS/openFDA)#

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