Virx Instant Hand Sanitizer Drug Facts

VIRX - instant hand sanitizer gel
Filo America

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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Active Ingredient...........................................................Purpose
Ethyl Alcohol 62%...........................................................................Antiseptic

Use to decrease bacteria on the skin.

Warnings
For external use only * Flammable * Keep away from fire or flame.

When using this product avoid contact with mouth, ears, and eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor if redness or irritation develops and lasts more than 72 hours.

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

Directions
Pump into palms and thoroughly rub into skin until dry.

Other Information * store at 20 degrees Celcius (68 degrees to 77 degrees Farenheit) * may discolor fabrics.

Deionized water, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, aminomethyl propanol, carbomer, fragrance and yellow 5.

MM1

MM2

VIRX
instant hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50438-807
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	496 mL in 800 mL

Ingredient Name	Strength
Inactive Ingredients
Carbomer 934 (UNII: Z135WT9208)

Product Characteristics
Color	yellow (yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:50438-807-15	300 mL in 1 BOTTLE, PUMP
2	NDC:50438-807-16	500 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333	02/11/2010

Labeler - Filo America (943873703)

Registrant - Filo America (943873703)

Name	Address	ID/FEI	Business Operations
Establishment
Dongyang Changdi Daily Sanitary Co., Ltd		528198683	manufacture