FDA.reportPublic FDA data

Aloha Gel Hand Sanitizer Tropical Berry

Manufacturer
Double Body Biotech Limited
Effective date
2020-06-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:17:47

Label at a glance#

ProductAloha Gel Hand Sanitizer Pineapple-Mango
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire and flame.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - DO NOT USE SECTION

If swallowed, seek medical attention immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

Store below 105°F

may discolor certain fabrics

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

(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.

PACKAGE LABEL.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; 74657-010-1074657-010-01; 74657-010-05; 74657-010-10

74657-011-0174657-011-01

74657-012-0174657-012-01

74657-013-0174657-013-01

74657-014-0174657-014-01

74657-015-0174657-015-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74657-010-012022-01-28C16284748780-1d6a99b39-f551-a426-e053-dadaa90af4c2Double Body Aloha Gel Hand Sanitizer
74657-010-052022-01-28C16284748780-1d6a99b39-f551-a426-e053-dadaa90af4c2Double Body Aloha Gel Hand Sanitizer
74657-010-102022-01-28C16284748780-1d6a99b39-f551-a426-e053-dadaa90af4c2Double Body Aloha Gel Hand Sanitizer
74657-011-012022-01-28C16284748780-1d6a99b39-f551-a426-e053-dadaa90af4c2Double Body Aloha Gel Hand Sanitizer
74657-012-012022-01-28C16284748780-1d6a99b39-f551-a426-e053-dadaa90af4c2Double Body Aloha Gel Hand Sanitizer
74657-013-012022-01-28C16284748780-1d6a99b39-f551-a426-e053-dadaa90af4c2Double Body Aloha Gel Hand Sanitizer
74657-014-012022-01-28C16284748780-1d6a99b39-f551-a426-e053-dadaa90af4c2Double Body Aloha Gel Hand Sanitizer
74657-015-012022-01-28C16284748780-1d6a99b39-f551-a426-e053-dadaa90af4c2Double Body Aloha Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74657-010-01Gel Hand Sanitizer with Aloe Vera100 mL in 1 BOTTLEGEL1002
74657-010-05Gel Hand Sanitizer with Aloe Vera500 mL in 1 BOTTLE, PUMPGEL5002
74657-010-10Gel Hand Sanitizer with Aloe Vera1000 mL in 1 BOTTLE, PUMPGEL10002
74657-011-01Aloha Gel Hand Sanitizer Vanilla60 mL in 1 BOTTLEGEL602
74657-012-01Aloha Gel Hand Sanitizer Tropical Berry60 mL in 1 BOTTLEGEL602
74657-013-01Aloha Gel Hand Sanitizer Pineapple-Mango60 mL in 1 BOTTLEGEL602
74657-014-01Aloha Gel Hand Sanitizer Pure Peppermint60 mL in 1 BOTTLEGEL602
74657-015-01Aloha Gel Hand Sanitizer Crazy Coconut60 mL in 1 BOTTLEGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74657-010ALOHA 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 [DOUBLE BODY BIOTECH LIMITED]2Legacy NDC, 3 package rows20200616_a7bf9587-e479-42ce-e053-2a95a90a122d.zip
74657-011ALOHA 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 [DOUBLE BODY BIOTECH LIMITED]2Legacy NDC, 1 package rows20200616_a7bf9587-e479-42ce-e053-2a95a90a122d.zip
74657-012ALOHA 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 [DOUBLE BODY BIOTECH LIMITED]2Legacy NDC, 1 package rows20200616_a7bf9587-e479-42ce-e053-2a95a90a122d.zip
74657-013ALOHA 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 [DOUBLE BODY BIOTECH LIMITED]2Legacy NDC, 1 package rows20200616_a7bf9587-e479-42ce-e053-2a95a90a122d.zip
74657-014ALOHA 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 [DOUBLE BODY BIOTECH LIMITED]2Legacy NDC, 1 package rows20200616_a7bf9587-e479-42ce-e053-2a95a90a122d.zip
74657-015ALOHA 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 [DOUBLE BODY BIOTECH LIMITED]2Legacy NDC, 1 package rows20200616_a7bf9587-e479-42ce-e053-2a95a90a122d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74657-01374657-013-01
74657-01474657-014-01
74657-01074657-010-01, 74657-010-05, 74657-010-10
74657-01574657-015-01
74657-01174657-011-01
74657-01274657-012-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 9804Q93RCW27EIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9804Q93RCW27EIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9804Q93RCW27EIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9804Q93RCW27EIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 9804Q93RCW27EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
FD&C RED NO. 40WZB9127XOAIACT
D&C RED NO. 339DBA0SBB0LIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a821f55e-48d6-d899-e053-2995a90a23e1a7bf9587-e479-42ce-e053-2a95a90a122d2020-06-15WarningsExact identifier
spl id: a821f55e-48d6-d899-e053-2995a90a23e1
spl set id: a7bf9587-e479-42ce-e053-2a95a90a122d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.