WONVIA ANTIBACTERIAL HAND DISINFECTANT GEL- alcohol gel

Wonvia Antibacterial Hand Disinfectant Gel by

Drug Labeling and Warnings

Wonvia Antibacterial Hand Disinfectant Gel 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: Antiseptic

Purpose

Antiseptic, Antibacterial Hand Disinfectant Gel

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

• keep away from children
• on open skin wounds
• do not use in the cleaning of foodstuffs

WHEN USING

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

Stop use and ask a doctor if irritation or rash occurs. 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.

Do not breathe directly.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. 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

• Use enough amount of solution to keep your hands wet. Rub hands together for 30 seconds.
• Keep away from children, food, and animal feed.
• Follow the instructions to avoid risks to human and environmental health.

Other information

• Store between 15-30C (59-86F) in its original packaging upright in a cool dry place that does not receive direct sunlight.
• Avoid freezing and excessive heat above 40C (104F)
• Do not store more than 4 boxes in a row.
• Dispose of the container P501 in accordance with local regulations.
• use the unpacked product within 1 month.
• Shelf life (25+/2C) of the product is 2 years.

Inactive ingredients

Softener 1.5%, Resolvent 28.19%, fragrance 0.1%, colouring 0.01%

resolvent is completed with 27.8%

proportion to 100%

Package Label - Principal Display Panel

1L NDC: 78876-710-10

5L NDC: 78876-710-50

INGREDIENTS AND APPEARANCE

WONVIA ANTIBACTERIAL HAND DISINFECTANT GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78876-710
Route of Administration	TOPICAL

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

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: 78876-710-10	1 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/30/2020
2	NDC: 78876-710-50	5 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/30/2020

Labeler - KAPLAN DISTRIBUTION LLC (117548994)

Registrant - KAPLAN DISTRIBUTION LLC (117548994)

Establishment
Name	Address	ID/FEI	Business Operations
RKS GROUP YAPI KIMYASALLARI SANAYI VE TICARET LIMITED SIRKETI		520136931	manufacture(78876-710)