BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES VANILLA SUGAR WINTER BERRY PEPPERMINT- benzalkonium chloride kit

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES Vanilla Sugar Winter Berry Peppermint by

Drug Labeling and Warnings

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES Vanilla Sugar Winter Berry Peppermint by is a Otc medication manufactured, distributed, or labeled by ENCHANTE ACCESSORIES INC., Zhejiang Ruolin Hygienic Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES Vanilla Sugar

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES Vanilla Sugar

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Use

■ To decrease bacteria on hands

WARNINGS

For external use only

When using this product avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water

Stop use and ask a doctor if irritation or rash occurs. This 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 at 1-800-222-1222

Directions

For adults and children two years and over

Peel over reusable label and remove a wipe from the packet.

Wet hands thoroughly and air dry.

Place used wipes into waste basket. Do not flush.

Inactive ingredients

Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES Winter Berry

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES Winter Berry

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose:

Antibacterial

Uses:

■ To decrease bacteria on hands

Warnings

For external use only

WHEN USING

When using this product avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water

Stop use and ask a doctor if irritation or rash occurs. This 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 at 1-800-222-1222

Directions

For adults and children two years and over

Peel over reusable label and remove a wipe from the packet.

Wet hands thoroughly and air dry.

Place used wipes into waste basket. Do not flush.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES Peppermint

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES Peppermint

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Uses

■ To decrease bacteria on hands

Warnings

For external use only

WHEN USING

When using this product avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water

Stop use and ask a doctor if irritation or rash occurs. This 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 at 1-800-222-1222

Directions

For adults and children two years and over

Peel over reusable label and remove a wipe from the packet.

Wet hands thoroughly and air dry.

Place used wipes into waste basket. Do not flush.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES VANILLA SUGAR WINTER BERRY PEPPERMINT 
benzalkonium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-362

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-362-01	1 in 1 KIT	10/20/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKET	20
Part 2	1 PACKET	20
Part 3	1 PACKET	20

Part 1 of 3

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES VANILLA SUGAR 
benzalkonium chloride solution

Product Information
Item Code (Source)	NDC: 50563-359
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	4.5 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-359-01	20 in 1 PACKET; 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	10/20/2020

Part 2 of 3

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES WINTER BERRY 
benzalkonium chloride solution

Product Information
Item Code (Source)	NDC: 50563-360
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	4.5 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-360-01	20 in 1 PACKET; 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	10/20/2020

Part 3 of 3

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES PEPPERMINT 
benzalkonium chloride solution

Product Information
Item Code (Source)	NDC: 50563-361
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	4.5 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-361-01	20 in 1 PACKET; 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	10/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/20/2020

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(50563-362)