FRAIS HAND SANITIZER - alcohol gel 
Frais Luxury Products

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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Frais Hand Sanitizer

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

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


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

444ml Product Label
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.)

FRAIS HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42587-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL66 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42587-001-016 g in 1 BOTTLE, PLASTIC
2NDC:42587-001-0250 g in 1 BOTTLE, PLASTIC
3NDC:42587-001-03444 g in 1 BOTTLE, PUMP
4NDC:42587-001-0414 in 1 BOX
4NDC:42587-001-016 g in 1 BOTTLE, PLASTIC
5NDC:42587-001-051 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33305/15/2008
Labeler - Frais Luxury Products (832784354)
Establishment
NameAddressID/FEIBusiness Operations
Frais Luxury Products Pty Ltd755387342manufacture

Revised: 12/2009
Document Id: 7c5132ea-889c-4813-ae70-6411961dad84
Set id: 7c5132ea-889c-4813-ae70-6411961dad81
Version: 4
Effective Time: 20091202
 
Frais Luxury Products