BODY PRESCRIPTIONS ANTIBACTERIAL WIPES ALOE SCENTED LEMON SCENTED FRESH CITRUS SCENTED- 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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BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES ALOE SCENTED

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES ALOE SCENTED

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Use

■ To decrease bacteria on hands

WARNINGS

For external use only

Stop Use

Do not use if you are allergic to any ingredients listed

Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

Do not get into eyes. Rinse thoroughly with water if contact occurs

keep out of reach of children

Keep out of reach of children

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

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

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES LEMON SCENTED

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES LEMON SCENTED

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose:

Antibacterial

Uses:

■ To decrease bacteria on hands

Warnings

For external use only

Stop Use

Do not use if you are allergic to any ingredients listed

Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

Do not get into eyes. Rinse thoroughly with water if contact occurs

Keep out of reach of children

Keep out of reach of children

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

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

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES FRESH CITRUS SCENTED

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES FRESH CITRUS SCENTED

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Uses

■ To decrease bacteria on hands

Warnings

For external use only

Stop Use

Do not use if you are allergic to any ingredients listed

Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

Do not get into eyes. Rinse thoroughly with water if contact occurs

Keep out of reach of children. 

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

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

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES ALOE SCENTED

image description

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES LEMON SCENTED

image description

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES FRESH CITRUS SCENTED

image description

BODY PRESCRIPTIONS ANTIBACTERIAL WIPES ALOE SCENTED LEMON SCENTED FRESH CITRUS SCENTED 
benzalkonium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-224
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-224-011 in 1 KIT06/12/2020
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 WIPES ALOE SCENTED 
benzalkonium chloride solution
Product Information
Item Code (Source)NDC:50563-221
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:50563-221-0120 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 finalpart333A06/12/2020
Part 2 of 3
BODY PRESCRIPTIONS ANTIBACTERIAL WIPES LEMON SCENTED 
benzalkonium chloride solution
Product Information
Item Code (Source)NDC:50563-222
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:50563-222-0120 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 finalpart333A06/12/2020
Part 3 of 3
BODY PRESCRIPTIONS ANTIBACTERIAL WIPES FRESH CITRUS SCENTED 
benzalkonium chloride solution
Product Information
Item Code (Source)NDC:50563-223
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:50563-223-0120 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 finalpart333A06/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/12/2020
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Ruolin Hygienic Products Co., Ltd.415426870manufacture(50563-224, 50563-221, 50563-222, 50563-223)

Revised: 6/2020
Document Id: a8046b65-4b25-d83f-e053-2995a90aa250
Set id: 58e9b8fb-21d3-4a59-9934-ba1ef3e3ce4b
Version: 1
Effective Time: 20200614
 
ENCHANTE ACCESSORIES INC.