BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZERS CRANBERRY WINTER BERRY PEPPERMINT- 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_317/318/319/320_G0XAHS07

BODY PRESCRIPTIONS Cranberry HAND SANITIZER ANTIBACTERIAL

BODY PRESCRIPTIONS Cranberry HAND SANITIZER ANTIBACTERIAL

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

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

Blue 1, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Water,  Yellow 5

BODY PRESCRIPTIONS Winter Berry HAND SANITIZER ANTIBACTERIAL

BODY PRESCRIPTIONS Winter Berry HAND SANITIZER ANTIBACTERIAL

Active Ingredient

Alcohol 75%

Purpose

Antiseptic

Uses

■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

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

Blue 1, Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Yellow 5

BODY PRESCRIPTIONS Peppermint HAND SANITIZER ANTIBACTERIAL

BODY PRESCRIPTIONS Peppermint HAND SANITIZER ANTIBACTERIAL

Active Ingredient

Alcohol 75%

Purpose

Antiseptic

Uses

■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

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

Blue 1, Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Yellow 5

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BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZERS CRANBERRY WINTER BERRY PEPPERMINT 
alcohol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-320
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-320-011 in 1 KIT10/09/2020
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 CRANBERRY HAND SANITIZER ANTIBACTERIAL 
alcohol solution
Product Information
Item Code (Source)NDC:50563-317
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)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-317-0160 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 finalpart333A10/09/2020
Part 2 of 3
BODY PRESCRIPTIONS WINTER BERRY HAND SANITIZER ANTIBACTERIAL 
alcohol solution
Product Information
Item Code (Source)NDC:50563-318
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)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-318-0160 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 finalpart333A10/09/2020
Part 3 of 3
BODY PRESCRIPTIONS PEPPERMINT HAND SANITIZER ANTIBACTERIAL 
alcohol solution
Product Information
Item Code (Source)NDC:50563-319
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)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-319-0160 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 finalpart333A10/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/09/2020
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(50563-320)

Revised: 10/2020
Document Id: b1425073-9050-6cff-e053-2a95a90a9f7d
Set id: 39cdd898-65e0-4888-83e3-16444cbf42eb
Version: 1
Effective Time: 20201009
 
ENCHANTE ACCESSORIES INC.