Tropical Scented Hand Sanitizer by GIFNI LIMITED GFNI Topical scented

Tropical Scented Hand Sanitizer by

Drug Labeling and Warnings

Tropical Scented Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by GIFNI LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TROPICAL SCENTED HAND SANITIZER- alcohol 70% gel 
GIFNI 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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GFNI Topical scented

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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 heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredients

Aqua/Water, Parfum/Fragrance, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Tocopheryl Acetate

Package Label - Principal Display Panel

TROPICAL SCENTED HAND SANITIZER 
alcohol 70% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90044-7000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.001 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.2 mL  in 100 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90044-7000-0	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	12/31/2021

Labeler - GIFNI LIMITED (221750044)

Revised: 10/2022

Document Id: ec070985-62b3-4ab0-e053-2995a90ac3a7

34390-5

Set id: adba9c89-8e64-74be-e053-2a95a90a7f85

Version: 4

Effective Time: 20221027