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NDC 86937-0008-05 medifresh Antiseptic Hand and Skin Disinfectant Wet Wipes 80 g/100g Details

medifresh Antiseptic Hand and Skin Disinfectant Wet Wipes 80 g/100g

medifresh Antiseptic Hand and Skin Disinfectant Wet Wipes is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI. The primary component is ALCOHOL.

Product Information

NDC	86937-0008
Product ID	86937-008_d177f614-57ea-447d-88e4-755c018ec6c5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	medifresh Antiseptic Hand and Skin Disinfectant Wet Wipes
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	80
Active Ingredient Units	g/100g
Substance Name	ALCOHOL
Labeler Name	KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 86937-0008-05 (86937000805)

Pricing Information	N/A
NDC Package Code	86937-008-05
Billing NDC	86937000805
Package	60 PACKAGE in 1 BOX (86937-008-05) / 3.2467 g in 1 PACKAGE
Marketing Start Date	2022-06-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL feae75fc-1f0d-47ea-9900-277f4504850b Details

Drug Facts

Active Ingredients

Ethyl Alcohol 80.0 % w / w

Purpose

Antiseptic

Uses

To decrease bacteria on the skin that could cause disease

Warnings

For external use only.

Flammable – Keep away from heat or flame

Do not use

              • as baby wipe

              • on open skin wounds

              • if you are allergic to any of the ingredients

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

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

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. Open container 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 90º angle. 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

Store in dry and cool place and away from oxidizers.

May discolor some fabrics, harmful to wood finishes and plastics.

Inactive ingredients

Aqua, Glycerin, Propylene Glycol, Parfum, Tocopheryl Acetate, Citric Acid, Aloe Barbadensis Extract, Benzalkonium Chloride

SPL UNCLASSIFIED SECTION

Moisturizer

Aloe Vera

Vitamin E

Decrease Bacteria that could cause disease

Non - Sterile Wet Wipe

MANUFACTURER

KARDEŞLER UÇAN YAĞLAR SANAYİ A.Ş.

İNÖNÜ MAHALLESİ GEBZE

PLASTİKÇİLER OSB MAHALLESİ

42.SOKAK NO:1 41400

GEBZE - KOCAELİ - TÜRKİYE

T +90 ( 0262 ) 751 29 30 ( Pbx)

www.kardeslerucanyaglar.com

[email protected]

Made In Turkey

Packaging

INGREDIENTS AND APPEARANCE

MEDIFRESH ANTISEPTIC HAND AND SKIN DISINFECTANT WET WIPES

ethyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:86937-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:86937-008-01	200 in 1 CANISTER	06/22/2022
1		1.512 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:86937-008-02	200 in 1 BOX	06/22/2022
2		3.240 g in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC:86937-008-03	80 in 1 CANISTER	06/22/2022
3		1.512 g in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC:86937-008-04	80 in 1 BOX	06/22/2022
4		3.240 g in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC:86937-008-05	60 in 1 BOX	06/22/2022
5		3.2467 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/22/2022

Labeler - KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI (644389322)

Name	Address	ID/FEI	Business Operations
Establishment
KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI		644389322	manufacture(86937-008)

Revised: 6/2022

Document Id: d177f614-57ea-447d-88e4-755c018ec6c5

Set id: feae75fc-1f0d-47ea-9900-277f4504850b

Version: 1

Effective Time: 20220623