DailyMed - MARINA AND DEMME HAPPY HANDS HAND SANITIZER SET UNSCENTED FRESH CITRUS COCONUT VANILLA- alcohol kit

Contains inactivated NDC Code(s)
NDC Code(s): 50563-284-01, 50563-285-01, 50563-286-01, 50563-287-01
Packager: ENCHANTE ACCESSORIES INC.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated October 8, 2020

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MARINA AND DEMME ANTIBACTERIAL HAND SANITIZER Unscented
MARINA AND DEMME ANTIBACTERIAL HAND SANITIZER Unscented - Active Ingredient - Alcohol 75% Purpose - Antiseptic

MARINA AND DEMME ANTIBACTERIAL HAND SANITIZER Unscented

Active Ingredient

Alcohol 75%

Purpose

Antiseptic

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

■ To decrease bacteria on the skin that could cause disease
■Recommended for repeated use
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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 ...
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
- in children less than two months of age
- on open skin wounds
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.

Close
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

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
Close
Other information
Do not store above 105F - May discolor some fabrics - Harmful to wood finishes and plastics

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics
Close
Inactive ingredients
Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Tocopheryl Acetate

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Tocopheryl Acetate
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MARINA AND DEMME ANTIBACTERIAL HAND SANITIZER Fresh Citrus
MARINA AND DEMME ANTIBACTERIAL HAND SANITIZER Fresh Citrus

MARINA AND DEMME ANTIBACTERIAL HAND SANITIZER Fresh Citrus
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Active Ingredient
Alcohol 75%

Alcohol 75%
Close
Purpose
Antiseptic

Antiseptic
Close
Uses
To decrease bacteria on the skin that could cause disease - ■Recommended for repeated use
- To decrease bacteria on the skin that could cause disease
■Recommended for repeated use
Close
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 ...
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
- in children less than two months of age
- on open skin wounds
Close
STOP USE
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition
Close
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.
Close
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

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
Close
Other Information
Do not store above 105F - May discolor some fabrics - Harmful to wood finishes and plastics

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics
Close
Inactive Ingredients
Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Tocopheryl Acetate, Red4, Yellow 5

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Tocopheryl Acetate, Red4, Yellow 5
Close
MARINA AND DEMME ANTIBACTERIAL HAND SANITIZER Coconut
MARINA AND DEMME ANTIBACTERIAL HAND SANITIZER Coconut

MARINA AND DEMME ANTIBACTERIAL HAND SANITIZER Coconut
Close
Active Ingredient
Alcohol 75%

Alcohol 75%
Close
Purpose
Antiseptic

Antiseptic
Close
Uses
To decrease bacteria on the skin that could cause disease - ■Recommended for repeated use
- To decrease bacteria on the skin that could cause disease
■Recommended for repeated use
Close
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 ...
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
- in children less than two months of age
- on open skin wounds
Close
DO NOT USE
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition
Close
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.
Close
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

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
Close
Other Information
Do not store above 105F - May discolor some fabrics - Harmful to wood finishes and plastics

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics
Close
Inactive Ingredients
Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Tocopheryl Acetate, Blue 1, Yellow 5

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Tocopheryl Acetate, Blue 1, Yellow 5
Close
PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

Product Information

MARINA AND DEMME HAPPY HANDS HAND SANITIZER SET UNSCENTED FRESH CITRUS COCONUT VANILLA alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50563-287

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50563-287-01	1 in 1 KIT	10/06/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	60 mL
Part 2	1 BOTTLE	60 mL
Part 3	1 BOTTLE	60 mL

Part 1 of 3

MARINA AND DEMME ANTIBACTERIAL HAND SANITIZER UNSCENTED alcohol solution

Product Information
Item Code (Source)	NDC:50563-284
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50563-284-01	60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/06/2020

Part 2 of 3

MARINA AND DEMME ANTIBACTERIAL HAND SANITIZER FRESH CITRUS alcohol solution

Product Information
Item Code (Source)	NDC:50563-285
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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 RED NO. 4 (UNII: X3W0AM1JLX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50563-285-01	60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/06/2020

Part 3 of 3

MARINA AND DEMME ANTIBACTERIAL HAND SANITIZER COCONUT alcohol solution

Product Information
Item Code (Source)	NDC:50563-286
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50563-286-01	60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/06/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/06/2020

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Name	Address	ID/FEI	Business Operations
Establishment
Xiamen Afgamarine Biotechnology Co., Ltd.		420485152	manufacture(50563-287)

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	RxCUI	RxNorm NAME	RxTTY
1	1047755	ethanol 75 % Topical Solution	PSN
2	1047755	ethanol 0.75 ML/ML Topical Solution	SCD
3	1047755	ethanol 75 % Topical Solution	SY

Label: MARINA AND DEMME HAPPY HANDS HAND SANITIZER SET UNSCENTED FRESH CITRUS COCONUT VANILLA- alcohol kit

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	NDC
1	50563-284-01
2	50563-285-01
3	50563-286-01
4	50563-287-01 (inactivated)

Label: MARINA AND DEMME HAPPY HANDS HAND SANITIZER SET UNSCENTED FRESH CITRUS COCONUT VANILLA- alcohol kit

View Package Photos

Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

Active Ingredient

Purpose

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Safety

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More Info on this Drug

MARINA AND DEMME HAPPY HANDS HAND SANITIZER SET UNSCENTED FRESH CITRUS COCONUT VANILLA- alcohol kit

Number of versions: 1

MARINA AND DEMME HAPPY HANDS HAND SANITIZER SET UNSCENTED FRESH CITRUS COCONUT VANILLA- alcohol kit

MARINA AND DEMME HAPPY HANDS HAND SANITIZER SET UNSCENTED FRESH CITRUS COCONUT VANILLA- alcohol kit

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MARINA AND DEMME HAPPY HANDS HAND SANITIZER SET UNSCENTED FRESH CITRUS COCONUT VANILLA- alcohol kit

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.