FDA.reportPublic FDA data

Ultraclean Antibacterial Wet Wipes

Manufacturer
AKGUN COCUK BEZI VE KOZMETIK URUNLERI SANAYI TICARET LIMITED SIRKETI
Effective date
2020-11-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:33:10

Label at a glance#

ProductUltraclean Antibacterial Wet Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Open package, remove one wet wipes to clean your hands and body. Reseal, keep closed to prevent evaporation. Allow to dry without wiping. Discard properly after use. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store at room temperature. Do not flush down toilet.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Benzalkonium Chloride (0.45%, volume/volume (w/v)) in an aqueous solution.
  2. Glycerol (0.8% w/v).
  3. Phenoxyethanol (0.1% w/v).
  4. Cocamidopropyl Betaine (0.4% w/v).
  5. Polysorbate 20 (0.2% w/v).
  6. Peg-7 Glyceryl Cocoate (0.3% w/v).
  7. Citric Acid (0.1% w/v).
  8. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.45% w/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer 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.

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. 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

  • Open package, remove one wet wipes to clean your hands and body. Reseal, keep closed to prevent evaporation.
  • Allow to dry without wiping. Discard properly after use.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature.
  • Do not flush down toilet.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, Cocoamidopropyl betaine, glycerin, Phenoxyethanol, Polysorbate 20, Peg-7 glyceryl cocoate, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72 pcs NDC: 86812-002-01 72 pcs72 pcs

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81026-003-012022-01-28C16284748780-1d6a99b39-7f33-a426-e053-dadaa90af4c2Ultraclean Antibacterial Wet Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81026-003-01Ultraclean Antibacterial Wet Wipes72 mL in 1 PACKAGECLOTH726

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81026-003ULTRACLEAN ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [AKGUN COCUK BEZI VE KOZMETIK URUNLERI SANAYI TICARET LIMITED SIRKETI]6Legacy NDC, 1 package rows20201107_b370ffa7-3d2e-2114-e053-2995a90a7e8f.zip

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
81026-00381026-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LIME OILUZH29XGA8GIACT

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
b370f0e6-aa88-e31d-e053-2a95a90a1c3ab370ffa7-3d2e-2114-e053-2995a90a7e8f2020-11-06WarningsExact identifier
spl id: b370f0e6-aa88-e31d-e053-2a95a90a1c3a
spl set id: b370ffa7-3d2e-2114-e053-2995a90a7e8f

Reported adverse events (FAERS/openFDA)#

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