WIPE OUT ANTIBACTERIAL WIPES 2 PACK 1 LEMON SCENT 1 FRESH SCENT- benzalkonium chloride kit

WIPE OUT ANTIBACTERIAL WIPES 2 PACK 1 lemon scent 1 fresh scent by

Drug Labeling and Warnings

WIPE OUT ANTIBACTERIAL WIPES 2 PACK 1 lemon scent 1 fresh scent by is a Otc medication manufactured, distributed, or labeled by TZUMI INNOVATIONS LLC, Zhangzhou Zhongnan Nursing Products Co., Ltd., Jinhua Aidi Daily Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WIPE OUT ANTIBACTERIAL WIPES lemon scent

WIPE OUT ANTIBACTERIAL WIPES lemon scent

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

■ To decrease bacteria on the skin that could cause disease

WARNINGS

For external use only

When using this product, keep out of eyes
In case of contact with eyes, flush thoroughly with water

Avoid contact with broken skin

Stop Use

Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours

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 without wiping

For children under 6, use only under adult supervision

Not recommended for infants

Other information

Keep containers tightly closed in a dry, cool and well ventilated place
Recommended storage temperature: 32F to 104F (0C to 40C)

Inactive ingredients

Aloe Barbadensis Leaf Juice, Fragrance, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate, Water

WIPE OUT ANTIBACTERIAL WIPES fresh scent

WIPE OUT ANTIBACTERIAL WIPES fresh scent

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

To decreases bacteria on the skin that could cause disease

Warnings

For external use only

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin

Stop Use

Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

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

Directions

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only under adult supervision

Not recommended for infants

Other Information

Keep containers tightly closed in a dry, cool and well ventilated place
Recommended storage temperature: 32F to 104F (0C to 40C)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Fragrance, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate, Water

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WIPE OUT ANTIBACTERIAL WIPES 2 PACK 1 LEMON SCENT 1 FRESH SCENT 
benzalkonium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77878-036

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77878-036-01	1 in 1 KIT	12/28/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CANISTER	80
Part 2	1 CANISTER	80

Part 1 of 2

WIPE OUT ANTIBACTERIAL WIPES LEMON SCENT 
benzalkonium chloride solution

Product Information
Item Code (Source)	NDC: 77878-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	5.85 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77878-034-01	80 in 1 CANISTER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/28/2020

Part 2 of 2

WIPE OUT ANTIBACTERIAL WIPES FRESH SCENT 
benzalkonium chloride solution

Product Information
Item Code (Source)	NDC: 77878-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	5.85 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77878-035-01	80 in 1 CANISTER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/28/2020

Labeler - TZUMI INNOVATIONS LLC (117426322)

Establishment
Name	Address	ID/FEI	Business Operations
Zhangzhou Zhongnan Nursing Products Co., Ltd.		416376835	manufacture(77878-036)

Establishment
Name	Address	ID/FEI	Business Operations
Jinhua Aidi Daily Chemical Co., Ltd.		547506401	manufacture(77878-036)