CLEAN HANDS WASH WITHOUT WATER- alcohol gel
PIERRE BEAUVAIS A/S

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

Ethyl alcohol 85%

PRESS OPEN on top of the tip-lid.
Turn the bottle upside down.
Squeeze out the gel in your hand. Rub it into your skin until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Purpose

Antiseptic.

Use

Handsanitizer gel eliminates viruses and bacteria instantly, for use when soap and water not available.

Warnings

For external use only.Flammable.
Keep away from heat or flame.

Do not use

On 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

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Inactive Ingredients.

Water,Hydroxypropylcellulose,Glycerin

Other Information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C ( 104F)

Product Label

image description

CLEAN HANDS WASH WITHOUT WATER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79908-009
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	85 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79908-009-01	90 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/15/2020

Labeler - PIERRE BEAUVAIS A/S (309510118)

Name	Address	ID/FEI	Business Operations
Establishment
Pierre Beauvais A/S		309510118	manufacture(79908-009)