BODY PRESCRIPTIONS HAND SANITIZER DUO ROSE WATER SCENTED PEPPERMINT SCENTED- 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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50563-397/398/399 G1ABHS07

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER ROSE WATER SCENTED

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER ROSE WATER SCENTED

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

Do not use

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

Stop use and ask a doctor if skin 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 right away at 1-800-222-1222

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, Fragrance, Glycerin, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Water

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER PEPPERMINT SCENTED

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER PEPPERMINT SCENTED

Active Ingredient

Alcohol 75%

Purpose

Antiseptic

Uses

■Recommended for repeated use

Warnings

For external use only. Flammable.

Keep away from heat or flame

Do not use

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Directions

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients

Carbomer, Fragrance, Glycerin, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Water

image description

image description

BODY PRESCRIPTIONS HAND SANITIZER DUO ROSE WATER SCENTED PEPPERMINT SCENTED 
alcohol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-399
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-399-011 in 1 KIT10/30/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 21 BOTTLE 30 mL
Part 1 of 2
BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER ROSE WATER SCENTED 
alcohol solution
Product Information
Item Code (Source)NDC:50563-397
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-397-0130 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 finalpart333A10/30/2020
Part 2 of 2
BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER PEPPERMINT SCENTED 
alcohol solution
Product Information
Item Code (Source)NDC:50563-398
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-398-0130 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 finalpart333A10/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/30/2020
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(50563-399)

Revised: 11/2020
Document Id: b30d9c99-2dba-04a7-e053-2995a90a6a58
Set id: f05f26f9-d9f2-408f-b405-8871e81978e4
Version: 1
Effective Time: 20201101
 
ENCHANTE ACCESSORIES INC.