MEDIFRESH HAND SKIN ANTISEPTIC DISINFECTANT WET WIPES- alcohol-benzalkonium chloride cloth

Medifresh Hand Skin Antiseptic Disinfectant Wet Wipes by

Drug Labeling and Warnings

Medifresh Hand Skin Antiseptic Disinfectant Wet Wipes by is a Otc medication manufactured, distributed, or labeled by KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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

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

WHEN USING

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

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

• 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

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

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

200 PCS NDC: 86937-002-01

INGREDIENTS AND APPEARANCE

MEDIFRESH HAND SKIN ANTISEPTIC DISINFECTANT WET WIPES 
alcohol-benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86937-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 g
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86937-002-01	200 g in 1 PACKAGE; Type 0: Not a Combination Product	07/20/2020
2	NDC: 86937-002-02	80 g in 1 PACKAGE; Type 0: Not a Combination Product	07/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/20/2020

Labeler - KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI (644389322)

Registrant - KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI (644389322)

Establishment
Name	Address	ID/FEI	Business Operations
KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI		644389322	manufacture(86937-002)