FDA.reportPublic FDA data

foam 103

Manufacturer
Alpha Aromatics
Effective date
2022-01-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:25

Label at a glance#

Productfoam 103
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Dosage and administration

To decrease bacteria on the skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather, and rinse.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.15%(w/w)

Purpose

OTC - PURPOSE SECTION

Anitbacterial

Use

INDICATIONS & USAGE SECTION

Handwash to help decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes. If eye contact occurs, flush eyes with water.

Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician.

OTC - STOP USE SECTION

Stop use if, in rare instances, redness or irrtiation develops. If condition persists for more than 72 hours, consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, contact a physician or poison control center.

Directions

DOSAGE & ADMINISTRATION SECTION

To decrease bacteria on the skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather, and rinse.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, glycerine, decyl glucoside, dmdm hydantoin, fragrance.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.78 L NDC: 75009-103-01

3787g label3787g label

18.92 L NDC: 75009-103-02

18933g label18933g label

208.19 L NDC: 75009-103-03

208269g label208269g label

1040.98 L NDC: 75009-103-04

1041556g label1041556g label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75009-103-012024-01-30C16284748780-11030e365-2b7b-111a-e063-dadaa90a10e2Antibacterial Green Apple Foaming Hand Soap
75009-103-022024-01-30C16284748780-11030e365-2b7b-111a-e063-dadaa90a10e2Antibacterial Green Apple Foaming Hand Soap
75009-103-032024-01-30C16284748780-11030e365-2b7b-111a-e063-dadaa90a10e2Antibacterial Green Apple Foaming Hand Soap
75009-103-042024-01-30C16284748780-11030e365-2b7b-111a-e063-dadaa90a10e2Antibacterial Green Apple Foaming Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75009-103-01foam 1033787 g in 1 JUGSOAP37872
75009-103-02foam 10318933 g in 1 PAILSOAP189332
75009-103-03foam 103208269 g in 1 DRUMSOAP2082692
75009-103-04foam 1031041556 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKSOAP10415562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75009-103FOAM 103 (ANTIBACTERIAL FOAMING SOAP) SOAP [ALPHA AROMATICS]2Legacy NDC, 4 package rows20220123_a6c9bad4-718c-618b-e053-2995a90a7211.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75009-10375009-103-01, 75009-103-02, 75009-103-03, 75009-103-04

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
DECYL GLUCOSIDEZ17H97EA6YIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL SOLUTION 70%8KW3E207O2IACT
DIHYDROMYRCENOL46L1B02ND9IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
HEXYL ACETATE7U7KU3MWT0IACT
WATER059QF0KO0RIACT
DMDM HYDANTOINBYR0546TOWIACT

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
d61e028c-1f5c-8d9d-e053-2995a90a1839a6c9bad4-718c-618b-e053-2995a90a72112022-01-21WarningsExact identifier
spl id: d61e028c-1f5c-8d9d-e053-2995a90a1839
spl set id: a6c9bad4-718c-618b-e053-2995a90a7211

Reported adverse events (FAERS/openFDA)#

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