BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS- alcohol kit

BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS by

Drug Labeling and Warnings

BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS 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]

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Spearmint

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Spearmint

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, Hands

Flammable. Keep away from heat and flame

When using this product, keep out of eyes. 
In case of contact with eyes, flush thoroughly with water

Avoid contact with broken skin

Do not inhale or ingest

Stop Use

Stop use and ask a doctor if skin irritation develops

keep out of reach of children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately

Directions

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only under adult supervision

Not recommended for infants

Other information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Blue 1, Yellow 5

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Unsented

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Unscented

ACTIVE INGREDIENT

Active Ingredient

Alcohol 75%

PURPOSE

Purpose:

Antiseptic

INDICATIONS & USAGE

Uses:

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

Warnings

For external use only, Hands

Flammable. Keep away from heat and flame

When using this product, keep out of eyes.
In case of contact with eyes, flush thoroughly with water

Avoid contact with broken skin

Do not inhale or ingest

Stop Use

Stop use and ask a doctor if skin irritation develops

Keep out of reach of children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately

Directions

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only under adult supervision

Not recommended for infants

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Red 33, Blue 1

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Citrus

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Citrus

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, Hands

Flammable. Keep away from heat and flame

When using this product, keep out of eyes.
In case of contact with eyes, flush thoroughly with water

Avoid contact with broken skin

Do not inhale or ingest

Stop Use

Stop use and ask a doctor if skin irritation develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately

Directions

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only under adult supervision

Not recommended for infants

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Yellow 5, Red 4

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS 
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-256

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-256-01	1 in 1 KIT	09/11/2020

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

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER SPEARMINT 
alcohol solution

Product Information
Item Code (Source)	NDC: 50563-253
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-253-01	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	09/11/2020

Part 2 of 3

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER UNSCENTED 
alcohol solution

Product Information
Item Code (Source)	NDC: 50563-254
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-254-01	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	09/11/2020

Part 3 of 3

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER CITRUS 
alcohol solution

Product Information
Item Code (Source)	NDC: 50563-255
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-255-01	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	09/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/11/2020

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Afgamarine Biotechnology Co., Ltd.		420485152	manufacture(50563-256)