FDA.reportPublic FDA data

Alpha

Manufacturer
Alpha Aromatics
Effective date
2022-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:08:24

Label at a glance#

ProductAlpha
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

Antibacterial

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 irritation 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

3.78L NDC: 75009-203-01

3.78L label3.78L label

18.933L NDC: 75009-203-02

18.933L label18.933L label

208.269L NDC: 75009-203-03

208.269L Label208.269L Label

1041.556L NDC: 75009-203-04

1041.556L Label1041.556L Label

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75009-20375009-203-01, 75009-203-02, 75009-203-03, 75009-203-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLAMEN ALDEHYDE4U37UX0E1EIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
DMDM HYDANTOINBYR0546TOWIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL SOLUTION 70%8KW3E207O2IACT

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
06809e92-1a62-b814-e063-6394a90a1978d8384af0-3409-44bd-e053-2a95a90aa3472023-09-29WarningsExact identifier
spl set id: d8384af0-3409-44bd-e053-2a95a90aa347

Reported adverse events (FAERS/openFDA)#

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