CAL STAT PLUS ANTISEPTIC HANDRUB WITH ENHANCED EMOLLIENTS- isopropyl alcohol liquid

Cal Stat Plus Antiseptic Handrub by

Drug Labeling and Warnings

Cal Stat Plus Antiseptic Handrub by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc., STERIS Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Isopropyl Alcohol 63% v/v

Purpose

Healthcare Personnel Handwash

Uses

• 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

For external use only.

Flammable. Keep away from fire or flame.

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Stop use and ask a doctor if skin irritation develops. If condition persists more than 3 days, consult a physician.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply product to hands and rub thoroughly until dry.

Inactive ingredients

Aqua (Water), Behentrimonium Methosulfate, Cetyl Lactate, Glycerin, Hydroxypropyl Cellulose, Methylpropanediol, Parfum (Fragrance), Phenoxyethanol, Polyquaternium-6.

Questions or comments?

1-866-783-0422

PRINCIPAL DISPLAY PANEL - 444 ml Bottle Label

Cal Stat® Plus
deb med®

NDC: 11084-804-13

Hand Sanitizer
Antiseptic Handrub with Enhanced Emollients

Excellent
Moisturization

15
seconds
Fast-acting

CHG Compatible

Net Contents: 444 ml (15 fl oz)

REORDER #
1181-RP

Manufactured for: Deb USA, Inc., Charlotte, NC 28217
1-866-783-0422 www.debmed.com

1181-14ESD(F)(917)
61952

INGREDIENTS AND APPEARANCE

CAL STAT PLUS ANTISEPTIC HANDRUB  WITH ENHANCED EMOLLIENTS
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-804
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302)	Isopropyl Alcohol	63 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
methylpropanediol (UNII: N8F53B3R4R)
phenoxyethanol (UNII: HIE492ZZ3T)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
glycerin (UNII: PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
POLYQUATERNIUM-6 (150000 MW) (UNII: 163BBM0B4X)
behentrimonium methosulfate (UNII: 5SHP745C61)

Product Characteristics
Color	YELLOW (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-804-41	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018
2	NDC: 11084-804-13	444 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018
3	NDC: 11084-804-03	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018
4	NDC: 11084-804-25	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/01/2018

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
STERIS Corporation		139424188	MANUFACTURE(11084-804)