PURELL WATERLESS SURGICAL SCRUB- alcohol liquid 
GOJO Industries, Inc.

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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PURELL Waterless Surgical Scrub

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

Inactive ingredients

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

Product Label

PURELL WATERLESS SURGICAL SCRUB 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-992
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21749-992-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2011
2NDC:21749-992-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2011
3NDC:21749-992-891200 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/15/2011
Labeler - GOJO Industries, Inc. (004162038)
Establishment
NameAddressID/FEIBusiness Operations
GOJO Industries, Inc.036424534MANUFACTURE(21749-992)
Establishment
NameAddressID/FEIBusiness Operations
GOJO Industries, Inc.088312414MANUFACTURE(21749-992) , label(21749-992) , pack(21749-992)

Revised: 10/2017
Document Id: fbeebc0d-12ed-4beb-89d5-c6389398d088
Set id: e3ed5e0c-1e21-47eb-a999-9c8aa5083dff
Version: 3
Effective Time: 20171002
 
GOJO Industries, Inc.