FDA.reportPublic FDA data

Aloe Formula

Manufacturer
BBC Group Ltd
Effective date
2020-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:18

Label at a glance#

ProductAloe Formula Antibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

■ Squeeze into hands and lather with water. Rinse well

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

When using this product

OTC - WHEN USING SECTION

■ do not get into eyes.

■ if contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ irritation and 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

■ Squeeze into hands and lather with water. Rinse well

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glyceryl Laurate, Phenoxyethanol, Fragrance, PEG-150 Distearate, Aloe Barbadensis Leaf Juice, Disodium EDTA, Citric Acid, Magnesium Chloride, Methylchloroisothiazolinone, Magnesium Nitrate, Methylisothiazolinone

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76383-019-082022-01-28C16284748780-1d6a99b39-a4b3-a426-e053-dadaa90af4c2Antibacterial Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76383-019-08Aloe FormulaAntibacterial236 mL in 1 BOTTLE, PLASTICSOAP2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76383-019ALOE FORMULA ANTIBACTERIAL (BENZALKONIUM CHLORIDE) SOAP [BBC GROUP LTD]1Legacy NDC, 1 package rows20200428_a447524e-ed2b-0e5a-e053-2995a90adb37.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76383-01976383-019-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLISOTHIAZOLINONE229D0E1QFAIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
EDETATE DISODIUM7FLD91C86KIACT
MAGNESIUM NITRATE77CBG3UN78IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ALOE VERA LEAFZY81Z83H0XIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
GLYCERYL LAURATEY98611C087IACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML · Source PDF

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
a4474267-a4e2-8e76-e053-2a95a90a0081a447524e-ed2b-0e5a-e053-2995a90adb372020-04-27WarningsExact identifier
spl id: a4474267-a4e2-8e76-e053-2a95a90a0081
spl set id: a447524e-ed2b-0e5a-e053-2995a90adb37

Reported adverse events (FAERS/openFDA)#

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