Medifresh Hand Skin Antiseptic Disinfectant Wet Wipes

Manufacturer
KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI
Effective date
2020-08-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:25:19

Label at a glance#

ProductMedifresh Hand Skin Antiseptic Disinfectant Wet Wipes
Active ingredientBENZALKONIUM CHLORIDE, ALCOHOL
Label structure13 sections

Dosage and administration

Open contaniner plastic cover. Tear off aluminum cover. From center of wipe roll, pull up wipe corner; Twist wipe corner from the center plastic cap, thread through the hole. Pull through about one inch. Replace plastic cover. Pull out wipes as needed and snap off at 90 angle. Wipe skin,hands, wrist and elbow ensuring wetting completely. Do not rinse after usage. Keep center cap closed to prevent moisture loss. Di...

Storage and handling

Store in dry and cool place and away from oxidizers. May discolor some fabrics, harmful to wood finishes and plastics.

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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Benzalkonium Chloride (0.1% w/w).
  3. Glycerol (0.2% w/w).
  4. Tocopheryl Acetate (0.05% w/w)
  5. Propylene Glycol (0.2% w/w).
  6. Aloe Barbadensis Extract (0.02% w/w)
  7. Citric acid (0.04% w/w)
  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

Alcohol 80% w/w

Benzalkonium Chloride 0.1% w/w .

Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand & Skin Sanitizer

Use

INDICATIONS & USAGE SECTION

Skin should be rubbed vigorously with the wet wipe. No need to rinse after usage. Allow skin to dry without wiping. For adults and children 2 years and over.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

do not use

  • as baby wipe
  • on open skin wounds
  • if you are allergic to any other ingredient.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.


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 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 contaniner plastic cover. Tear off aluminum cover. From center of wipe roll, pull up wipe corner; Twist wipe corner from the center plastic cap, thread through the hole. Pull through about one inch. Replace plastic cover. Pull out wipes as needed and snap off at 90 angle. Wipe skin,hands, wrist and elbow ensuring wetting completely. Do not rinse after usage. Keep center cap closed to prevent moisture loss. 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 in dry and cool place and away from oxidizers.
  • May discolor some fabrics, harmful to wood finishes and plastics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerol, Propylene Glycol, Parfum, Tocopheryl Acetate, Citric acid, Aloe Barbadensis Extract

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80 PCS NDC: 86937-002-02

80 pis80 pis

200 PCS NDC: 86937-002-01

200 pcs200 pcs

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2387202benzalkonium chloride 0.1 % / ethanol 80 % Medicated PadPSN3
2387202benzalkonium chloride 1 MG/ML / ethanol 0.8 ML/ML Medicated PadSCD3
2387202benzalkonium chloride 0.1 % / ethanol 80 % Medicated PadSY3

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86937-002-01Medifresh Hand Skin Antiseptic Disinfectant Wet Wipes200 g in 1 PACKAGECLOTH2003
86937-002-02Medifresh Hand Skin Antiseptic Disinfectant Wet Wipes80 g in 1 PACKAGECLOTH803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86937-002MEDIFRESH HAND SKIN ANTISEPTIC DISINFECTANT WET WIPES (ALCOHOL-BENZALKONIUM CHLORIDE) CLOTH [KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI]3Legacy NDC, 2 package rows20200821_ab537628-11ff-1edc-e053-2995a90a63b9.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86937-00286937-002-01, 86937-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
ad5587c1-eedc-6a43-e053-2995a90ad1bbab537628-11ff-1edc-e053-2995a90a63b92020-08-20WarningsExact identifier
spl id: ad5587c1-eedc-6a43-e053-2995a90ad1bb
spl set id: ab537628-11ff-1edc-e053-2995a90a63b9

Reported adverse events (FAERS/openFDA)#

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