FDA.reportPublic FDA data

Purity Bleu Antibacterial

Manufacturer
Alben Internacional, S.A. de C.V.
Effective date
2020-10-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:35

Label at a glance#

ProductPurity Bleu Antibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Directions - pump into DRY hands - lather vigorously for at least 15 seconds - rinse and dry thoroughly Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzethonium Chloride 0.13% v/v. Purpose: Antibacterial

Purpose

OTC - PURPOSE SECTION

Antibacterial, Hand Soap

Use

INDICATIONS & USAGE SECTION

Uses - For handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Directions - pump into DRY hands - lather vigorously for at least 15 seconds - rinse and dry thoroughly
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, SODIUM LAURYL ETHER SULFATE, COCAMIDOPROPYL BETAINE, COCAMIDE DIETHANOLAMINE, GLYCERIN, ALOE BARBADENSIS EXTRACT, FRAGRANCE, BENZOPHENONE-4, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, Can Contain: RED No. 40 (CI 16035), RED No. 33 (CI 17200), BLUE No. 1 (CI 42090), YELLOW No. 5 (CI 19140), GREEN No. 3 (CI 42053), VIOLET 2 (CI 60730)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 ml NDC:80955-010-01

250250

1000 ml NDC:80955-010-02

10001000

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80955-010-012022-01-28C16284748780-1d6a99b39-497d-a426-e053-dadaa90af4c2b2beb979-8fd1-9842-e053-2995a90ae5f9
80955-010-022022-01-28C16284748780-1d6a99b39-497d-a426-e053-dadaa90af4c2b2beb979-8fd1-9842-e053-2995a90ae5f9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80955-010-01Purity Bleu Antibacterial250 mL in 1 BOTTLE, PUMPSOLUTION2501
80955-010-02Purity Bleu Antibacterial1000 mL in 1 BOTTLE, DISPENSINGSOLUTION10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80955-010PURITY BLEU ANTIBACTERIAL (BENZALKONIUM CHLORIDE) SOLUTION [ALBEN INTERNACIONAL, S.A. DE C.V.]1Legacy NDC, 2 package rows20201029_b2beb979-8fd1-9842-e053-2995a90ae5f9.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80955-01080955-010-01, 80955-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
BENZOPHENONE-5853Z42ZYASIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
COCO DIETHANOLAMIDE92005F972DIACT
GLYCERINPDC6A3C0OXIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
SODIUM LAURYL SULFATE368GB5141JIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
WATER059QF0KO0RIACT
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
b2beb979-8fc3-9842-e053-2995a90ae5f9b2beb979-8fd1-9842-e053-2995a90ae5f92020-10-28WarningsExact identifier
spl id: b2beb979-8fc3-9842-e053-2995a90ae5f9
spl set id: b2beb979-8fd1-9842-e053-2995a90ae5f9

Reported adverse events (FAERS/openFDA)#

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