FDA.reportPublic FDA data

Pro-Sanitize

Manufacturer
Clean Beauty Concepts
Effective date
2020-08-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:15

Label at a glance#

ProductPro-Sanitize
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser holde in cover. Keep lid closed to prevent moisture loss. Open and unfold wipe Thoroughly wipe hands, fingers and wrists. Be sure to use the entire wipe. Allow to dry. For dirty hands, use first wipe to clean hands, then discard wipe, sanitize with the second wipe. Discard after single use Supervise child...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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

  1. Benzalkonium Chloride (
  2. Glycerol
  3. Hydrogen peroxide
  4. Sterile distilled water or boiled cold water.
  5. Fragrance (Parfum)
  6. Aloe vera leaf extract
  7. Vitamin E

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Antiseptic wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warnings

WARNINGS SECTION

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

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

  • To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser holde in cover. Keep lid closed to prevent moisture loss.
  • Open and unfold wipe
  • Thoroughly wipe hands, fingers and wrists. Be sure to use the entire wipe. Allow to dry.
  • For dirty hands, use first wipe to clean hands, then discard wipe, sanitize with the second wipe.
  • Discard after single use
  • 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(aqua), glycerin, hydrogen peroxide, fragrance(parfum), Aloe Barbadensis, Tocopheryl Acetate Vitamin E

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80ct NDC: 76665-012 80 Antiseptic wipes80 Antiseptic wipes-80

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76665-012-802022-01-28C16284748780-1d6a99b39-6079-a426-e053-dadaa90af4c2adf2393a-98aa-07cb-e053-2995a90aa16b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76665-012-80Pro-Sanitize789 mL in 1 CANISTERLIQUID7891

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76665-012PRO-SANITIZE (BENZALKONIUM CHLORIDE) LIQUID [CLEAN BEAUTY CONCEPTS]1Legacy NDC, 1 package rows20200829_adf2393a-98aa-07cb-e053-2995a90aa16b.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76665-01276665-012-80

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
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE VERA LEAFZY81Z83H0XIACT

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
adf2229c-196d-0d5c-e053-2995a90af032adf2393a-98aa-07cb-e053-2995a90aa16b2020-08-28WarningsExact identifier
spl id: adf2229c-196d-0d5c-e053-2995a90af032
spl set id: adf2393a-98aa-07cb-e053-2995a90aa16b

Reported adverse events (FAERS/openFDA)#

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