BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES WINTER BERRY PEPPERMINT VANILLA MINT- benzalkonium chloride 
ENCHANTE ACCESSORIES INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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50563-355/356/357/358 G0XABW02

BODY PRESCRIPTIONS Antibacterial HAND WIPES WINTER BERRY

BODY PRESCRIPTIONS Antibacterial HAND WIPES WINTER BERRY

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 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 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 VANILLA MINT

BODY PRESCRIPTIONS Antibacterial HAND WIPES VANILLA MINT

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Uses

■ 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

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BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES WINTER BERRY PEPPERMINT VANILLA MINT 
benzalkonium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-358
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-358-011 in 1 KIT10/20/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 20 
Part 21 PACKET 20 
Part 31 PACKET 20 
Part 1 of 3
BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES WINTER BERRY 
benzalkonium chloride solution
Product Information
Item Code (Source)NDC:50563-355
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE4.5 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-355-0120 in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/20/2020
Part 2 of 3
BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES PEPPERMINT 
benzalkonium chloride solution
Product Information
Item Code (Source)NDC:50563-356
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE4.5 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-356-0120 in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/20/2020
Part 3 of 3
BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES VANILLA MINT 
benzalkonium chloride solution
Product Information
Item Code (Source)NDC:50563-357
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE4.5 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-357-0120 in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/20/2020
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Ruolin Hygienic Products Co., Ltd.415426870manufacture(50563-358)

Revised: 10/2020
Document Id: b2214284-2771-d08d-e053-2995a90a6a21
Set id: 6a8d03e9-94e1-4ee3-8591-520a16660e8c
Version: 1
Effective Time: 20201020
 
ENCHANTE ACCESSORIES INC.