Island Pure Hand Sanitizer Soothing Gel Infused with Aloe Vera

Island Pure Hand Sanitizer Soothing Infused with Aloe Vera by

Drug Labeling and Warnings

Island Pure Hand Sanitizer Soothing Infused with Aloe Vera by is a Otc medication manufactured, distributed, or labeled by Tropical Isle Producers Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ISLAND PURE HAND SANITIZER SOOTHING INFUSED WITH ALOE VERA- alcohol gel 
Tropical Isle Producers Inc.

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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Island Pure Hand Sanitizer Soothing Gel Infused with Aloe Vera

DRUG FACTS

Active ingredient

Ethyl Alcohol 70%

Purpose

Antimicrobial

USE

Hand sanitizer to help reduce bacteria on the skin.

WARNINGS

Flammable. Keep away from fire or flame.

For external use only.

When using this product 

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask doctor if

irritation or rash appears and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

  • Put enough product in your palm to cover hands and rub hands together until dry.
  • Children under 6 years of age should be supervised when using this product.

OTHER INFORMATION

  • Store below 110°F (43°C).
  • May discolor certain fabric surfaces.

INACTIVE INGREDIENTS

Water/Aqua, Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Carbomer, Aminomethyl Propanol.

Package Labeling:

Label3Label4

ISLAND PURE HAND SANITIZER SOOTHING INFUSED WITH ALOE VERA 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78944-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78944-004-05147 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/31/202012/31/2022
Labeler - Tropical Isle Producers Inc. (076295001)

Revised: 10/2022
Document Id: eb506e9c-abef-357e-e053-2995a90a9533
Set id: a8b170dc-67c3-3995-e053-2995a90a9329
Version: 2
Effective Time: 20221018