FLOVELL CARE ANTIBACTERIAL WET WIPES

Manufacturer
INOSER INSAAT IC VE DIS TICARET ANONIM SIRKETI | LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI
Effective date
2020-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:34:41

Label at a glance#

ProductFLOVELL CARE ANTIBACTERIAL WET WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Open package, remove one wet wipe 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 (0.2%, weight/weight (w/w))
  2. GLYCERYL OLEATE
  3. LAURYL GLUCOSIDE
  4. PANTHENOL
  5. PHENOXYETHANOL
  6. OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER
  7. PROPYLENE GLYCOL
  8. COCAMIDOPROPYL BETAINE
  9. DICAPRYLYL CARBONATE
  10. FATTY-ACID AMIDE HYDROLASE 1
  11. GLYCERIN
  12. ALLANTOIN
  13. WATER
  14. BENZOIC ACID
  15. ANHYDROUS CITRIC ACID
  16. DEHYDROACETIC ACID
  17. ALOE VERA LEAF
  18. POLYSORBATE 20

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 0.2 % ( w/w ) Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Standard usage Antibacterial Wet Wipes: Soak the closed and impermable package inside hot water until it gets warm.

Microwave usage: Heat the package at 750 W for 20 seconds by tag label side openyl.

Antibacterial wet wipes: whenever is necessary and needed, it can be used as 1 piece for patients to wipes.

It is used to celan who is incontinent position in need bath.

Wet 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.

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 do not use in or near eyes. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs.

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 wipe 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

GLYCERYL OLEATE, LAURYL GLUCOSIDE, PANTHENOL, PHENOXYETHANOL, OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER, PROPYLENE GLYCOL, COCAMIDOPROPYL BETAINE, DICAPRYLYL CARBONATE, FATTY-ACID AMIDE HYDROLASE 1, GLYCERIN, ALLANTOIN, WATER, BENZOIC ACID, ANHYDROUS CITRIC ACID, DEHYDROACETIC ACID
ALOE VERA LEAF, POLYSORBATE 20

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72 pcs NDC: 86001-001-02

72 pcs72 pcs

15 pcs NDC 86001-001-04

15 pcs15 pcs

100 pcs NDC: 86001-001-06

100 PCS100 PCS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2360919benzalkonium Cl 0.2 % Medicated PadPSN2
2360919benzalkonium chloride 2 MG/ML Medicated PadSCD2
2360919benzalkonium chloride 0.2 % Medicated WipeSY2

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86001-001-01FLOVELL CARE ANTIBACTERIAL WET WIPES0.008524 g in 1 PATCHCLOTH0.0085242
86001-001-02FLOVELL CARE ANTIBACTERIAL WET WIPES72 in 1 PACKAGECLOTH722
86001-001-03FLOVELL CARE ANTIBACTERIAL WET WIPES0.008524 g in 1 PATCHCLOTH0.0085242
86001-001-04FLOVELL CARE ANTIBACTERIAL WET WIPES15 in 1 PACKAGECLOTH152
86001-001-05FLOVELL CARE ANTIBACTERIAL WET WIPES0.008524 g in 1 PATCHCLOTH0.0085242
86001-001-06FLOVELL CARE ANTIBACTERIAL WET WIPES100 in 1 PACKAGECLOTH1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86001-001FLOVELL CARE ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [INOSER INSAAT IC VE DIS TICARET ANONIM SIRKETI]2Legacy NDC, 6 package rows20201207_b5c6d3f4-7cff-2e7f-e053-2995a90a0b8e.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86001-00186001-001-01, 86001-001-02, 86001-001-05, 86001-001-06, 86001-001-03, 86001-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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
b5cd9feb-f518-60ee-e053-2995a90a3524b5c6d3f4-7cff-2e7f-e053-2995a90a0b8e2020-12-06WarningsExact identifier
spl id: b5cd9feb-f518-60ee-e053-2995a90a3524
spl set id: b5c6d3f4-7cff-2e7f-e053-2995a90a0b8e

Reported adverse events (FAERS/openFDA)#

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