FDA.reportPublic FDA data

PRIMORY Antimicrobial Foam

Manufacturer
GOJO Industries, Inc.
Effective date
2024-11-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:39:03

Label at a glance#

ProductPRIMORY Antimicrobial Foam
Active ingredientCHLOROXYLENOL
Label structure7 sections

Indications and uses

Handwash to help decrease bacteria on the skin Recommended for repeated use

Dosage and administration

Wet hands Apply a small amount of product and work into a lather Rinse well and dry hands completely

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.3%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • Handwash to help decrease bacteria on the skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this productdo 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 ifirritation 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

  • Wet hands
  • Apply a small amount of product and work into a lather
  • Rinse well and dry hands completely

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Alcohol, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Propylene Glycol, Ammonium Xylenesulfonate, Cocamide MEA, Glycerin, Isopropyl Alcohol, Lactic Acid, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Ammonium Sulfate, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 6 (CI 15985)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21749-555-432023-08-01C16284748780-10191ceaa-6479-198a-e063-dbdaa90aec3ePRIMORY Antimicrobial Foam Soap
21749-555-672023-08-01C16284748780-10191ceaa-6479-198a-e063-dbdaa90aec3ePRIMORY Antimicrobial Foam Soap
21749-555-892023-08-01C16284748780-10191ceaa-6479-198a-e063-dbdaa90aec3ePRIMORY Antimicrobial Foam Soap
21749-555-902023-08-01C16284748780-10191ceaa-6479-198a-e063-dbdaa90aec3ePRIMORY Antimicrobial Foam Soap
21749-555-432023-07-28C16284748780-10191ceaa-6479-198a-e063-dbdaa90aec3ePRIMORY Antimicrobial Foam Soap
21749-555-672023-07-28C16284748780-10191ceaa-6479-198a-e063-dbdaa90aec3ePRIMORY Antimicrobial Foam Soap
21749-555-892023-07-28C16284748780-10191ceaa-6479-198a-e063-dbdaa90aec3ePRIMORY Antimicrobial Foam Soap
21749-555-902023-07-28C16284748780-10191ceaa-6479-198a-e063-dbdaa90aec3ePRIMORY Antimicrobial Foam Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21749-555-43PRIMORY Antimicrobial Foam1500 mL in 1 PACKAGELIQUID15004
21749-555-67PRIMORY Antimicrobial Foam2000 mL in 1 PACKAGELIQUID20004
21749-555-89PRIMORY Antimicrobial Foam1200 mL in 1 PACKAGELIQUID12004
21749-555-90PRIMORY Antimicrobial Foam1250 mL in 1 PACKAGELIQUID12504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21749-555PRIMORY ANTIMICROBIAL FOAM (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]4Current NDC, Legacy NDC, 4 package rows20241127_18549702-f95f-447f-a551-4c2156f0667d.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21749-55521749-555-89, 21749-555-90, 21749-555-43, 21749-555-67

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
AMMONIUM LAURETH-2 SULFATE698O4Z48G6IACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
AMMONIUM XYLENESULFONATE4FZY6L6XCMIACT
COCO MONOETHANOLAMIDEC80684146DIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
LACTIC ACID33X04XA5ATIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
JOJOBA OIL724GKU717MIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
CORN OIL8470G57WFMIACT
AMMONIUM SULFATESU46BAM238IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C RED NO. 4X3W0AM1JLXIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
CHLOROXYLENOL0F32U78V2QACTIB

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
PRIMORY Antimicrobial FoamCHLOROXYLENOLGOJO Industries, Inc.18549702-f95f-447f-a551-4c2156f0667d2024-11-26WarningsExact identifier
ndc (package): 21749-555-43
ndc (package): 21749-555-67
ndc (package): 21749-555-89
ndc (package): 21749-555-90
ndc (product): 21749-555
ndc11 (package): 21749055567
ndc11 (package): 21749055589
ndc11 (package): 21749055543
ndc11 (package): 21749055590
spl id: 27d4814b-9337-65eb-e063-6394a90add35
spl set id: 18549702-f95f-447f-a551-4c2156f0667d

Reported adverse events (FAERS/openFDA)#

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