SURGICEPT  WATERLESS, SURGICAL HANDSCRUB AND HEALTHCARE PERSONNEL HANDWASH- ethyl alcohol solution 
HEALTHPOINT, LTD

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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SURGICEPT WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash – alcohol solution

CareFusion

Drug Facts

Active ingredient

Ethyl alcohol 70% w/w

Purpose

Antiseptic

Uses

Warnings

Directions

Other information

Inactive ingredients

Behentrimonium methosulfate, benzalkonium chloride, butylene glycol, cetyl alcohol, chlorhexidine gluconate, ethylhexylglycerin, isopropyl alcohol, phenoxyethanol, polyquaternium-10, PPG-3 myristyl ether, water.

Questions?

Please call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST) or visit our web site www.surgicept.com.

PRINCIPAL DISPLAY PANEL

NDC 0064-1080-59

Surgicept ®

Ethyl alcohol 70% w/w

WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash

2 fl oz (59 ml)
129464-1010

Marketed by:
CareFusion, Leawood, KS 66211

Manufactured for:
Healthpoint, Ltd., Fort Worth, TX 76107
by DPT Laboratories, Ltd., San Antonio, TX 78215

REORDER NO. 0064-1080-59
PATENT NO. 6,846,846

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5503959a-figure-01
SURGICEPT   WATERLESS, SURGICAL HANDSCRUB AND HEALTHCARE PERSONNEL HANDWASH
ethyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0064-1080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (CLEAR) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0064-1080-5959 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2006
2NDC:0064-1080-111150 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/2006
3NDC:0064-1080-801 in 1 CARTON01/01/200602/28/2015
3800 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/2006
Labeler - HEALTHPOINT, LTD (965634504)
Establishment
NameAddressID/FEIBusiness Operations
DPT LABORATORIES, LTD832224526manufacture(0064-1080)

Revised: 9/2017
Document Id: 58f2bf97-8743-5857-e053-2a91aa0a13ff
Set id: 96fe2cc7-e812-4d39-8f11-bd3cc7411a21
Version: 4
Effective Time: 20170911
 
HEALTHPOINT, LTD