CAL STAT PLUS  ANTISEPTIC- isopropyl alcohol liquid 
STERIS Corporation

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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CAL STAT® PLUS
Antiseptic Handrub with
Enhanced Emollients

Drug Facts

Active ingredient

63% v/v Isopropyl Alcohol

Purpose

Healthcare Personnel Handwash

Use

Healthcare Personnel Handwash in patient care procedures to decrease transient bacteria on the skin and reduce the risk of cross-contamination. Use when hands are physically clean.

Warnings

Flammable, keep away from fire or flame.

For external use only. Do not get in the eyes. Eye Irritant. If splashed in eyes, rinse promptly and thoroughly with water.

Discontinue use if irritation and redness develop. If irritation persists for more than 5 days, consult a physician.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Apply product to hands and rub thoroughly until dry.

Inactive Ingredients

Deionized Water, Methylpropanediol, Phenoxyethanol, Cetyl Lactate, Glycerin, Hydroxypropyl Cellulose, Polyquaternium-6, Behentrimonium Methosulfate, Fragrance

Questions or comments?

800-548-4873 www.steris.com

PRINCIPAL DISPLAY PANEL - 1.05 qt Bottle Label

NDC 0519-1181-41

CAL STAT® PLUS

Antiseptic Handrub with
Enhanced Emollients

1 Liter SDS (33.8 fl oz) (1.05 qt)

ANTIMICROBIAL

1181-87

Principal Display Panel - 1.05 qt Bottle Label
CAL STAT PLUS   ANTISEPTIC
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0519-1181
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Isopropyl Alcohol (Isopropyl Alcohol) Isopropyl Alcohol63 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water 
methylpropanediol 
phenoxyethanol 
lactic acid 
glycerin 
hydroxypropyl cellulose 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0519-1181-411000 mL in 1 BOTTLE
2NDC:0519-1181-13444 mL in 1 BOTTLE
3NDC:0519-1181-03118 mL in 1 BOTTLE
4NDC:0519-1181-2559 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A03/18/2011
Labeler - STERIS Corporation (139424188)
Establishment
NameAddressID/FEIBusiness Operations
STERIS Corporation139424188MANUFACTURE

Revised: 3/2011
Document Id: 40d7e0e0-5d45-48d7-a493-7ec279946af4
Set id: 72b35c1f-d65b-443e-9348-50b239bd5ffe
Version: 1
Effective Time: 20110325
 
STERIS Corporation