BODY PRESCRIPTIONS ANTIBACTERIAL WIPES ALOE SCENTED LEMON SCENTED FRESH CITRUS SCENTED- benzalkonium chloride kit

BODY PRESCRIPTIONS ANTIBACTERIAL WIPES ALOE SCENTED LEMON SCENTED FRESH CITRUS SCENTED by

Drug Labeling and Warnings

BODY PRESCRIPTIONS ANTIBACTERIAL WIPES ALOE SCENTED LEMON SCENTED FRESH CITRUS SCENTED 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 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

Active Ingredient

Benzalkonium Chloride 0.1%

PURPOSE

Purpose:

Antibacterial

INDICATIONS & USAGE

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

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

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES LEMON SCENTED

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES FRESH CITRUS SCENTED

INGREDIENTS AND APPEARANCE

BODY PRESCRIPTIONS ANTIBACTERIAL WIPES ALOE SCENTED LEMON SCENTED FRESH CITRUS SCENTED 
benzalkonium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-224

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-224-01	1 in 1 KIT	06/12/2020

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 WIPES ALOE SCENTED 
benzalkonium chloride solution

Product Information
Item Code (Source)	NDC: 50563-221
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: 50563-221-01	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	06/12/2020

Part 2 of 3

BODY PRESCRIPTIONS ANTIBACTERIAL WIPES LEMON SCENTED 
benzalkonium chloride solution

Product Information
Item Code (Source)	NDC: 50563-222
Route of 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: 50563-222-01	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	06/12/2020

Part 3 of 3

BODY PRESCRIPTIONS ANTIBACTERIAL WIPES FRESH CITRUS SCENTED 
benzalkonium chloride solution

Product Information
Item Code (Source)	NDC: 50563-223
Route of 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: 50563-223-01	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	06/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/12/2020

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(50563-224, 50563-221, 50563-222, 50563-223)