FRAIS HAND SANITIZER- alcohol gel

Frais Hand Sanitizer by

Drug Labeling and Warnings

Frais Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Frais Luxury Products, Frais Luxury Products Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl alcohol (66%)

USE

For hand washing to decrease bacteria on the skin.

WARNINGS

Do not ingest.  Do not use in eyes.  Supervise children’s use.  Flammable.

DIRECTIONS

Place a dollop into hands without water. Rub together until dry.

OTHER INFORMATION

Keep away from fire or flame. Store at normal room temperature. Avoid freezing conditions.

INACTIVE INGREDIENTS

Aqua, Citrus Aurantium Dulcis Peel Oil, Melaleuca Quinquenervia Oil, Citrus Grandis Peel Oil, Backhousia Citriodora Leaf Oil, Ocimum Basilicum Oil, Citrus Tangerina Peel Oil, Elettaria Cardamomum Seed Oil, Zingiber Officinale Root Oil, Methylcellulose

INFORMATION FOR PATIENTS

Not tested on animals.  Made in China from Australian blended essential oils and local ingredients.  Recyclable.

HOW SUPPLIED

FRAIS LUXURY PRODUCTS PTY LTD
4/59 Bream St, Coogee NSW 2034 Australia.
Los Angeles, USA    London, UK
www.frais.com.au

PRINCIPAL DISPLAY PANEL

Frais™

HAND SANITIZER

Les Huit

WITH GINGER, TANGERINE,

LEMON MYRTLE, NIAOULI, ORANGE,

BASIL, GRAPEFRUIT AND CARDAMOM

KILLS 99.9% OF GERMS

66% Sugarcane Alcohol.  ℮ 444ml (15fl. oz.)

INGREDIENTS AND APPEARANCE

FRAIS HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42587-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	66 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)	1 g  in 100 g
WATER (UNII: 059QF0KO0R)	32 g  in 100 g
VACCINIUM MYRTILLUS LEAF (UNII: Y4U591OU70)
ORANGE (UNII: 5EVU04N5QU)
GRAPEFRUIT (UNII: O82C39RR8C)
TANGERINE (UNII: KH3E3096OO)
CARDAMOM (UNII: 8BC4CUT4JL)
MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E)
BASIL (UNII: 2U0KZP0FDW)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42587-001-01	6 g in 1 BOTTLE, PLASTIC
2	NDC: 42587-001-02	50 g in 1 BOTTLE, PLASTIC
3	NDC: 42587-001-03	444 g in 1 BOTTLE, PUMP
4	NDC: 42587-001-04	14 in 1 BOX
4	NDC: 42587-001-01	6 g in 1 BOTTLE, PLASTIC
5	NDC: 42587-001-05	1 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	05/15/2008

Labeler - Frais Luxury Products (832784354)

Establishment
Name	Address	ID/FEI	Business Operations
Frais Luxury Products Pty Ltd		755387342	manufacture