FDA.reportPublic FDA data

Fresh Detox Antibacterial Wet Wipes

Manufacturer
AQUA KOZMETIK DIS TICARET ANONIM SIRKETI
Effective date
2020-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:57

Label at a glance#

ProductFresh Detox Antibacterial Wet Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

wet wipes to decrease bacteria on the skin recommended for repeated use for use when soap and water are not available

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping discard wipe in trash receptacle after use supervise children under 6 years of age when using this product to avoid swallowing

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • wet wipes to decrease bacteria on the skin
  • recommended for repeated use
  • 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 years of age
  • on open skin wounds
  • if you are allergic to any of the ingredients

When using this product 

OTC - WHEN USING SECTION

do not get into eyes. In case of contact, rinse eyes thoroughly with water for 15-20 minutes. Remove contact lenses, if present.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

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

  • wet hands thoroughly with product and allow to dry without wiping
  • discard wipe in trash receptacle after use
  • supervise children under 6 years of age when using this product to avoid swallowing

Other information

SPL UNCLASSIFIED SECTION

  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)
  • may discolour certain fabric or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, peg 7glyceryl cocoate, polysorbate 20, cocamidopropyl betaine, phenoxyethanol, dehydroacetic acid, benzoic acid, fragrance, edetate sodium, citric acid

Questions?

OTC - QUESTIONS SECTION

You may also report serious side effects to this mail adress? 

info@aquakozmetic.com.tr

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79997-001-012022-01-28C16284748780-1d6a99b39-cf2e-a426-e053-dadaa90af4c2Fresh Detox Antibacterial Wet Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79997-001-01Fresh Detox Antibacterial Wet Wipes2.875 mL in 1 PATCHCLOTH2.8751
79997-001-01Fresh Detox Antibacterial Wet Wipes80 in 1 BOXCLOTH801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79997-001FRESH DETOX ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [AQUA KOZMETIK DIS TICARET ANONIM SIRKETI]1Legacy NDC, 2 package rows20210115_b7b12a16-eea2-d6a2-e053-2a95a90a0b86.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
79997-00179997-001-01

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
WATER059QF0KO0RIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
POLYSORBATE 207T1F30V5YHIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DEHYDROACETIC ACID2KAG279R6RIACT
BENZOIC ACID8SKN0B0MIMIACT
EDETATE SODIUMMP1J8420LUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
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
b7b11f40-db75-401c-e053-2a95a90a6605b7b12a16-eea2-d6a2-e053-2a95a90a0b862020-12-30WarningsExact identifier
spl id: b7b11f40-db75-401c-e053-2a95a90a6605
spl set id: b7b12a16-eea2-d6a2-e053-2a95a90a0b86

Reported adverse events (FAERS/openFDA)#

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