BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER- 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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G0ABHS06

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER UNSCENTED

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER UNSCENTED

Active Ingredient

Alcohol Denat. 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, Tocopheryl Acetate

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER FRESH CITRUS

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER FRESH CITRUS

Active Ingredient

Alcohol Denat. 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, Tocopheryl Acetate, Yellow 5, Red 4

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER COCONUT VANILLA

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER COCONUT VANILLA

Active Ingredient

Alcohol Denat 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, Tocopheryl Acetate, Yellow 5, Blue 1

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER UNSCENTED

image description

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Fresh Citrus

image description

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER COCONUT VANILLA

image description

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER 
alcohol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-210
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-210-011 in 1 KIT06/05/2020
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 UNSCENTED 
alcohol solution
Product Information
Item Code (Source)NDC:50563-207
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)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-207-0160 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 finalpart333A06/05/2020
Part 2 of 3
BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER FRESH CITRUS 
alcohol solution
Product Information
Item Code (Source)NDC:50563-208
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)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-208-0160 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 finalpart333A06/05/2020
Part 3 of 3
BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER COCONUT VANILLA 
alcohol solution
Product Information
Item Code (Source)NDC:50563-209
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)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-209-0160 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 finalpart333A06/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/04/2020
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Chengda Industrial Co.,Ltd540042034manufacture(50563-210)

Revised: 6/2020
Document Id: a7581142-6956-36ec-e053-2995a90a0b99
Set id: 7b54c9a6-547b-4998-979b-48d44e008dc7
Version: 1
Effective Time: 20200605
 
ENCHANTE ACCESSORIES INC.