WONVIA INDIVIDUALLY WRAPPED ANTIBACTERIAL HAND WIPES 70% ALCOHOL- alcohol cloth

WONVIA INDIVIDUALLY WRAPPED ANTIBACTERIAL HAND WIPES 70% ALCOHOL by

Drug Labeling and Warnings

WONVIA INDIVIDUALLY WRAPPED ANTIBACTERIAL HAND WIPES 70% ALCOHOL by is a Otc medication manufactured, distributed, or labeled by KAPLAN DISTRIBUTION LLC, RKS GROUP YAPI KIMYASALLARI SANAYI VE TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 58%

Isopropyl Alcohol 12%

Alkyl Dimethyl Benzyl Ammonium Chloride 0.2%

Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Wipes

Use

Single-use hand wipes to help reduce bacteria on the skin. For use when soap and water are not available.

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and/or redness develop. These may be signs of a serious condition.

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 and/or redness develop. These may be signs of a serious condition.

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

• Wet hands thoroughly with product and allow to dry.
• Discard wipes in a trash receptacle after use. Do not flush.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store between 15-30C (59-86F) at room temperature.
• Avoid freezing and excessive heat above 40C (104F)
• Flammable keep away from fire.

Inactive ingredients

Softener 1.5%

Resolvent 28.19%

Fragrance 0.1%

Coloring 0.01%

Excipients and its amount (%): The resolvent is completed 27.8%

Proportion to 100%

Package Label - Principal Display Panel

50 individually wrapped hand wipes= NDC: 78876-713-50

INGREDIENTS AND APPEARANCE

WONVIA INDIVIDUALLY WRAPPED ANTIBACTERIAL HAND WIPES 70% ALCOHOL 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78876-713
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	58 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.2 g  in 100 g
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78876-713-50	50 g in 1 BOX; Type 0: Not a Combination Product	08/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/31/2020

Labeler - KAPLAN DISTRIBUTION LLC (117548994)

Registrant - KAPLAN DISTRIBUTION LLC (117548994)

Establishment
Name	Address	ID/FEI	Business Operations
KAPLAN DISTRIBUTION LLC		117548994	relabel(78876-713)

Establishment
Name	Address	ID/FEI	Business Operations
RKS GROUP YAPI KIMYASALLARI SANAYI VE TICARET LIMITED SIRKETI		520136931	manufacture(78876-713)