BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS- alcohol 
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_253/254/255/256_G0ABHS12

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

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, 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. 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

image description

image description

BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS 
alcohol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-256
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-256-011 in 1 KIT09/11/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 60 mL
Part 21 BOTTLE 60 mL
Part 31 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-253-0160 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/11/2020
Part 2 of 3
BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER UNSCENTED 
alcohol solution
Product Information
Item Code (Source)NDC:50563-254
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-254-0160 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/11/2020
Part 3 of 3
BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER CITRUS 
alcohol solution
Product Information
Item Code (Source)NDC:50563-255
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-255-0160 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/11/2020
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(50563-256)

Revised: 9/2020
Document Id: af7b647c-1f3f-68ec-e053-2995a90a219d
Set id: 7e65d47d-8229-445e-88fc-8e90d2670aaa
Version: 1
Effective Time: 20200916
 
ENCHANTE ACCESSORIES INC.