BEAUTY CONCEPTS HAND SANITIZER TRIO ROSE WATER PINK PEONY CHERRY BLOSSOM- alcohol kit

beauty concepts HAND SANITIZER TRIO ROSE WATER PINK PEONY CHERRY BLOSSOM by

Drug Labeling and Warnings

beauty concepts HAND SANITIZER TRIO ROSE WATER PINK PEONY CHERRY BLOSSOM by is a Otc medication manufactured, distributed, or labeled by ENCHANTE ACCESSORIES INC., Xiamen Afgamarine Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

beauty concepts ANTIBACTERIAL HAND SANITIZER ROSE WATER

beauty concepts ANTIBACTERIAL HAND SANITIZER ROSE WATER

Active Ingredient

Alcohol 75%

Purpose

Antiseptic

Use

■ To decrease bacteria on the skin that could cause disease
■Recommended for repeated use

WARNINGS

For external use only

Flammable. Keep away from heat or flame

When using this product, keep out of eyes, ears, and mouth 
In case of contact with eyes, rinse eyes thoroughly with water

Do not use

• in children less than 2 months of age
• on open skin wounds

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing

Other information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Carbomer, Glycerin, PEG-40 Hydrogenated Castor Oil, Red 4, Triethanolamine, Water

beauty concepts ANTIBACTERIAL HAND SANITIZER PINK PEONY

beauty concepts ANTIBACTERIAL HAND SANITIZER PINK PEONY

Active Ingredient

Alcohol 75%

Purpose

Antiseptic

Uses

• To decrease bacteria on the skin that could cause disease

■Recommended for repeated use

Warnings

For external use only

Flammable. Keep away from heat or flame

When using this product, keep out of eyes, ears, and mouth
In case of contact with eyes, rinse eyes thoroughly with water

Do not use

• in children less than two months of age
• on open skin wounds

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These 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.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients

Carbomer, Glycerin, PEG-40 Hydrogenated Castor Oil, Red 4, Triethanolamine, Water, Yellow 5

beauty concepts ANTIBACTERIAL HAND SANITIZER CHERRY BLOSSOM

beauty concepts ANTIBACTERIAL HAND SANITIZER CHERRY BLOSSOM

Active Ingredient

Alcohol 75%

Purpose

Antiseptic

Uses

• To decrease bacteria on the skin that could cause disease

■Recommended for repeated use

Warnings

For external use only

Flammable. Keep away from heat or flame

When using this product, keep out of eyes, ears, and mouth
In case of contact with eyes, rinse eyes thoroughly with water

Do not use

• in children less than 2 months of age
• on open skin wounds

DO NOT USE

Stop use and ask a doctor if irritation or rash occurs. These 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.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients

Carbomer, Glycerin, PEG-40 Hydrogenated Castor Oil, Red 4, Triethanolamine, Water

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BEAUTY CONCEPTS HAND SANITIZER TRIO ROSE WATER PINK PEONY CHERRY BLOSSOM 
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-390

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-390-01	1 in 1 KIT	10/31/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	60 mL
Part 2	1 BOTTLE	60 mL
Part 3	1 BOTTLE	60 mL

Part 1 of 3

BEAUTY CONCEPTS ANTIBACTERIAL HAND SANITIZER ROSE WATER 
alcohol solution

Product Information
Item Code (Source)	NDC: 50563-387
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-387-01	60 mL in 1 BOTTLE; 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	10/31/2020

Part 2 of 3

BEAUTY CONCEPTS ANTIBACTERIAL HAND SANITIZER PINK PEONY 
alcohol solution

Product Information
Item Code (Source)	NDC: 50563-388
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-388-01	60 mL in 1 BOTTLE; 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	10/31/2020

Part 3 of 3

BEAUTY CONCEPTS ANTIBACTERIAL HAND SANITIZER CHERRY BLOSSOM 
alcohol solution

Product Information
Item Code (Source)	NDC: 50563-389
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-389-01	60 mL in 1 BOTTLE; 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	10/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/31/2020

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Afgamarine Biotechnology Co., Ltd.		420485152	manufacture(50563-390)