MEDIFRESH HAND SKIN ANTISEPTIC DISINFECTANT WET WIPES- alcohol-benzalkonium chloride cloth 
KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MEDIFRESH HAND&SKIN ANTISEPTIC DISINFECTANT WET WIPES

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)

Alcohol 80% w/w

Benzalkonium Chloride 0.1% w/w .

Purpose: Antiseptic

Purpose

Antiseptic, Hand & Skin Sanitizer

Use

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

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

Do not use

do not use

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.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

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

Package Label - Principal Display Panel

80 PCS NDC: 86937-002-02

80 pis

200 PCS NDC: 86937-002-01

200 pcs

MEDIFRESH HAND SKIN ANTISEPTIC DISINFECTANT WET WIPES 
alcohol-benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86937-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.05 g  in 100 g
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.04 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.02 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.2 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 0.2 g  in 100 g
WATER (UNII: 059QF0KO0R) 19.19 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86937-002-01200 g in 1 PACKAGE; Type 0: Not a Combination Product07/20/2020
2NDC:86937-002-0280 g in 1 PACKAGE; Type 0: Not a Combination Product07/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/20/2020
Labeler - KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI (644389322)
Registrant - KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI (644389322)
Establishment
NameAddressID/FEIBusiness Operations
KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI644389322manufacture(86937-002)

Revised: 8/2020
Document Id: ad5587c1-eedc-6a43-e053-2995a90ad1bb
Set id: ab537628-11ff-1edc-e053-2995a90a63b9
Version: 3
Effective Time: 20200820
 
KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI