FDA.reportPublic FDA data

Prosanitize

Manufacturer
Clean Beauty Concepts
Effective date
2020-07-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:39

Label at a glance#

ProductProsanitize
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

• Pump onto dry hands. Lather vigorously for at least 15 seconds, Rinse and dry thorougly. • Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

The hand soap is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

  1. Benzalkonium chloride
  2. Water(aqua),
  3. sodium lauroyl sarcosinate,
  4. sodium cocoyl isethionate,
  5. cocamidopropyl betaine,
  6. cocamidopropyl
  7. PG-dimonium chloride phosphate,
  8. glycerin, polyquaternium-7,
  9. PEG-150 distearate,
  10. phenoxyethanol,
  11. sodium benzoate,
  12. citric acid,
  13. sodium chloride,
  14. tetrasodium EDTA,
  15. fragrance (parfum).

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.1% v/v. Purpose: Antibacterial

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

Antibacterial soap to help reduce bacteria on skin that potentially can cause disease.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

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.

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

• Pump onto dry hands. Lather vigorously for at least 15 seconds, Rinse and dry thorougly.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water(aqua), sodium lauroyl sarcosinate, sodium cocoyl isethionate, cocamidopropyl betaine, cocamidopropyl
PG-dimonium chloride phosphate, glycerin, polyquaternium-7, PEG-150 distearate, phenoxyethanol, sodium benzoate, citric acid, sodium chloride, tetrasodium EDTA, fragrance (parfum).

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 mL NDC: 76665-005-08

8oz8oz

3785 mL NDC: 76665-005-01

1gal1gal

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76665-005-012022-01-28C16284748780-1d6a99b39-7935-a426-e053-dadaa90af4c2ab0cb376-924a-5dde-e053-2a95a90aa655
76665-005-082022-01-28C16284748780-1d6a99b39-7935-a426-e053-dadaa90af4c2ab0cb376-924a-5dde-e053-2a95a90aa655

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76665-005-01Prosanitize3785 mL in 1 BOTTLE, DISPENSINGSOAP37851
76665-005-08Prosanitize236 mL in 1 BOTTLE, DISPENSINGSOAP2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76665-005PROSANITIZE (BENZALKONIUM CHLORIDE) SOAP [CLEAN BEAUTY CONCEPTS]1Legacy NDC, 2 package rows20200814_ab0cb376-924a-5dde-e053-2a95a90aa655.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
76665-00576665-005-08, 76665-005-01

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
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CHLORIDE451W47IQ8XIACT
FRAGRANCE LEMON ORC2001060K1725A7G95IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
GLYCERINPDC6A3C0OXIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
SODIUM BENZOATEOJ245FE5EUIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT

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
ab0cb6b6-d644-9b7d-e053-2995a90a373eab0cb376-924a-5dde-e053-2a95a90aa6552020-07-22WarningsExact identifier
spl id: ab0cb6b6-d644-9b7d-e053-2995a90a373e
spl set id: ab0cb376-924a-5dde-e053-2a95a90aa655

Reported adverse events (FAERS/openFDA)#

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