ALOHA GEL HAND SANITIZER PINEAPPLE-MANGO- aloha gel hand sanitizer pineapple-mango gel 
ALOHA GEL HAND SANITIZER PURE PEPPERMINT- aloha gel hand sanitizer pure peppermint gel 
GEL HAND SANITIZER WITH ALOE VERA- gel hand sanitizer with aloe vera gel 
ALOHA GEL HAND SANITIZER CRAZY COCONUT- aloha gel hand sanitizer crazy coconut gel 
ALOHA GEL HAND SANITIZER VANILLA- aloha gel hand sanitizer vanilla gel 
ALOHA GEL HAND SANITIZER TROPICAL BERRY- aloha gel hand sanitizer tropical berry gel 
Double Body Biotech Limited

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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Double Body Aloha Gel Hand Sanitizer

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 and consult a doctor if irritation or rash appears.

Keep out of reach of children.

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.

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

74657-010-01; 74657-010-05; 74657-010-10

74657-011-01

74657-012-01

74657-013-01

74657-014-01

74657-015-01

ALOHA GEL HAND SANITIZER PINEAPPLE-MANGO 
aloha gel hand sanitizer pineapple-mango gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74657-013
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74657-013-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/10/2020
ALOHA GEL HAND SANITIZER PURE PEPPERMINT 
aloha gel hand sanitizer pure peppermint gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74657-014
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74657-014-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/11/2020
GEL HAND SANITIZER WITH ALOE VERA 
gel hand sanitizer with aloe vera gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74657-010
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74657-010-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
2NDC:74657-010-05500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/11/2020
3NDC:74657-010-101000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/11/2020
ALOHA GEL HAND SANITIZER CRAZY COCONUT 
aloha gel hand sanitizer crazy coconut gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74657-015
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
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74657-015-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/11/2020
ALOHA GEL HAND SANITIZER VANILLA 
aloha gel hand sanitizer vanilla gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74657-011
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74657-011-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/10/2020
ALOHA GEL HAND SANITIZER TROPICAL BERRY 
aloha gel hand sanitizer tropical berry gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74657-012
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74657-012-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/10/2020
Labeler - Double Body Biotech Limited (560246954)
Registrant - Double Body Biotech Limited (560246954)

Revised: 6/2020
Document Id: a821f55e-48d6-d899-e053-2995a90a23e1
Set id: a7bf9587-e479-42ce-e053-2a95a90a122d
Version: 2
Effective Time: 20200615
 
Double Body Biotech Limited