NICOLE MILLER NEW YORK ANTIBACTERIAL HAND WIPES COCONUT VANILLA WARM SUGAR HONEY ALMOND 3 PACK- 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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50563-449/450/451/452 G1XABW14

nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Coconut Vanilla

nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Coconut Vanilla

Active Ingredient

Benzalkonium Chloride 0.13%

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 resealable 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

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

nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Warm Sugar

nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Warm Sugar

Active Ingredient

Benzalkonium Chloride 0.13%

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 resealable 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

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

nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Honey Almond

nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Honey Almond

Active Ingredient

Benzalkonium Chloride 0.13%

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 resealable 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

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

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NICOLE MILLER NEW YORK ANTIBACTERIAL HAND WIPES COCONUT VANILLA WARM SUGAR HONEY ALMOND 3 PACK 
benzalkonium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-452
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-452-011 in 1 KIT07/02/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 120 APPLICATOR 120 mL
Part 220 APPLICATOR 120 mL
Part 320 APPLICATOR 120 mL
Part 1 of 3
NICOLE MILLER NEW YORK ANTIBACTERIAL HAND WIPES COCONUT VANILLA 
benzalkonium chloride solution
Product Information
Item Code (Source)NDC:50563-449
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
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:50563-449-0120 in 1 PACKET
16 mL in 1 APPLICATOR; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/02/2021
Part 2 of 3
NICOLE MILLER NEW YORK ANTIBACTERIAL HAND WIPES WARM SUGAR 
benzalkonium chloride solution
Product Information
Item Code (Source)NDC:50563-450
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
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:50563-450-0120 in 1 PACKET
16 mL in 1 APPLICATOR; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/02/2021
Part 3 of 3
NICOLE MILLER NEW YORK ANTIBACTERIAL HAND WIPES HONEY ALMOND 
benzalkonium chloride solution
Product Information
Item Code (Source)NDC:50563-451
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
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:50563-451-0120 in 1 PACKET
16 mL in 1 APPLICATOR; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/02/2021
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Caring Cleaning Commodity Co., Ltd413905445manufacture(50563-452)

Revised: 7/2021
Document Id: c628595d-f5c6-fd2c-e053-2995a90a8ac2
Set id: 8fe6590e-402a-4932-a306-27589e2b3e4b
Version: 1
Effective Time: 20210702
 
ENCHANTE ACCESSORIES INC.