Purell Waterless Surgical Scrub (Alcohol) Liquid [Gojo Industries, Inc.] -

PURELL WATERLESS SURGICAL SCRUB (ALCOHOL) LIQUID [GOJO INDUSTRIES, INC.]
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NDC	21749-992-02, 21749-992-33, 21749-992-89
Set ID	e3ed5e0c-1e21-47eb-a999-9c8aa5083dff
Category	HUMAN OTC DRUG LABEL
Packager	GOJO Industries, Inc.
Generic Name
Product Class
Product Number
Application Number	PART333E

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Active ingredient

Ethyl alcohol 70% v/v
Purpose

Antiseptic surgical hand scrub
Uses

Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
Warnings

Flammable. Keep away from fire or flame.

For external use only

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase the risk of sunburn. Take steps to limit sun exposure while using this product and for one week following use.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- clean under the nails with a nail pick
- mails should be maintained with a 1 millimeter free edge
- place 2 mL of product into palm of one hand
- dip fingers of opposite hand into the product and work under nails
- spread remaining product evenly over the hands and lower 2/3 of one forearm paying particular attention to the nails, cuticles, and interdigital spaces
- place 2 mL of product into opposite hand and repeat steps above
- allow to air dry completely
Inactive ingredients

Water (Aqua), Isopropyl Myristate, Glycerin, Diisopropyl Sebacate, Citric Acid, PEG/PPG-20/6 Dimethicone, Tetradibutyl Pentaerythrityl Hydroxyhydrocinnamate, Hydroxypropylcellulose, Polyquaternium-37, Methylchloroisothiazolinone, Methylisothiazolinone
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURELL WATERLESS SURGICAL SCRUB
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-992
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:21749-992-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2011
2	NDC:21749-992-33	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2011
3	NDC:21749-992-89	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/15/2011

Labeler - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	MANUFACTURE(21749-992)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		088312414	MANUFACTURE(21749-992) , label(21749-992) , pack(21749-992)

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Medic

PURELL WATERLESS SURGICAL SCRUB (ALCOHOL) LIQUID [GOJO INDUSTRIES, INC.]

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