Label: 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

  • 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 June 15, 2020

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  • 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

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

    74657-011-01

    74657-012-01

    74657-013-01

    74657-014-01

    74657-015-01

  • INGREDIENTS AND APPEARANCE
    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)
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