ALOHA GEL HAND SANITIZER PINEAPPLE-MANGO gel ALOHA GEL HAND SANITIZER PURE PEPPERMINT gel GEL HAND SANITIZER WITH ALOE VERA gel ALOHA GEL HAND SANITIZER CRAZY COCONUT gel ALOHA GEL HAND SANITIZER VANILLA gel ALOHA GEL HAND SANITIZER TROPICAL BERRY gel

Aloha Gel Hand Sanitizer Tropical Berry by

Drug Labeling and Warnings

Aloha Gel Hand Sanitizer Tropical Berry by is a Otc medication manufactured, distributed, or labeled by Double Body Biotech Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Flammable, keep away from fire and flame.

STOP USE

Stop use and consult a doctor if irritation or rash appears.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DO NOT USE

If swallowed, seek medical attention immediately.

Directions

Wet hands thoroughly with gel, rub vigorously and allow to dry without wiping.

Other information

Store below 105°F

may discolor certain fabrics

Inactive Ingredient:

(only for Package NDC: 74657-010-01; 74657-010-05; 74657-010-10)*

Water, Glycerin, Carbomer, Propylene Glycol, Aloe Barbadensis Leaf Extract.

(only for Package NDC: 74657-011-01)*

Water, Glycerin, Carbomer, Propylene Glycol, Aloe Vera Leaf, Frangrance, FD&C Red No. 40, FD&C Yellow No. 5.

(only for Package NDC: 74657-012-01)*

Water, Glycerin, Carbomer, Propylene Glycol, Aloe Vera Leaf, Frangrance, FD&C Red No. 33.

(only for Package NDC: 74657-013-01)*

Water, Glycerin, Carbomer, Propylene Glycol, Aloe Vera Leaf, Frangrance, FD&C Red 40, FD&C Yellow No. 5.

(only for Package NDC: 74657-014-01)*

Water, Glycerin, Carbomer, Propylene Glycol, Aloe Vera Leaf, Frangrance, FD&C Blue No. 1, FD&C Yellow No. 5.

(only for Package NDC: 74657-015-01)*

Water, Glycerin, Carbomer, Propylene Glycol, Aloe Vera Leaf, Frangrance

*Remark: , All words in the brackets are not shown on the labels.

PRINCIPAL DISPLAY PANEL

1000ml, Package NDC: 74657-010-10; 500ml, Package NDC: 74657-010-05; 100ml, Package NDC: 74657-010-01; 60ml, Product NDC: 74657-011-01; 60ml, Product NDC: 74657-012-01; 60ml, Product NDC: 74657-013-01; 60ml, Product NDC: 74657-013-01; 60ml, Product NDC: 74657-014-01; 60ml, Product NDC: 74657-015-01

INGREDIENTS AND APPEARANCE

ALOHA GEL HAND SANITIZER PINEAPPLE-MANGO 
aloha gel hand sanitizer pineapple-mango gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74657-013
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 980 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74657-013-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020

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

ALOHA GEL HAND SANITIZER PURE PEPPERMINT 
aloha gel hand sanitizer pure peppermint gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74657-014
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 980 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74657-014-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/11/2020

GEL HAND SANITIZER WITH ALOE VERA 
gel hand sanitizer with aloe vera gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74657-010
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 980 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74657-010-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020
2	NDC: 74657-010-05	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/11/2020
3	NDC: 74657-010-10	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/11/2020

ALOHA GEL HAND SANITIZER CRAZY COCONUT 
aloha gel hand sanitizer crazy coconut gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74657-015
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 980 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74657-015-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/11/2020

ALOHA GEL HAND SANITIZER VANILLA 
aloha gel hand sanitizer vanilla gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74657-011
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 980 (UNII: 4Q93RCW27E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74657-011-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020

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

ALOHA GEL HAND SANITIZER TROPICAL BERRY 
aloha gel hand sanitizer tropical berry gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74657-012
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 980 (UNII: 4Q93RCW27E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74657-012-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020

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

Labeler - Double Body Biotech Limited (560246954)

Registrant - Double Body Biotech Limited (560246954)