ALCARE PLUS FOAMED ANTISEPTIC HANDRUB- alcohol aerosol, foam

Alcare Plus Foamed Antiseptic Handrub by

Drug Labeling and Warnings

Alcare Plus Foamed Antiseptic Handrub by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc., Accra Pac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Uses

• Surgical Scrub significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
• Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatment.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When using this product

• avoid contact with eyes. If splashed in eyes, rinse promptly and thoroughly with water.
• do not puncture or incinerate; contents under pressure.

Stop use and ask a doctor if

• irritation and redness develop. If irritation persists for more than 3 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

• Surgical Scrub Clean under nails with a pick. Nails should be maintained with a 1 mm free edge. Dispense 5 grams (tennis ball) onto one hand. Spread on both hands, paying particular attention to the nails, cuticles, and interdigital spaces and forearms. Rub into skin until dry. Dispense 2.5 grams (golf ball) onto one hand and spread over both hands to the wrists and rub into the skin until dry.
• Healthcare Personnel Handwash Apply product to hands and rub until thoroughly dry.

Other information

Do not store above 120°F (49°C). For best foam density store and use at 55 - 85°F (13 - 29°C).

Inactive ingredients

Aqua (Water), Hydrofluorocarbon 152A, Isobutane, Emulsifying Wax, Polyquaternium-6, Sodium Benzoate, Propane, Sodium Sesquicarbonate

Questions or comments?

1-866-783-0422

PRINCIPAL DISPLAY PANEL - 153 g Can Label

Alcare® Plus
deb med®

NDC: 11084-803-57

Hand Sanitizer
Foamed Antiseptic Handrub

Excellent
Moisturization

15
seconds
Fast Acting

CHG Compatible

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

Net Weight: 153 g (5.4 oz)

REORDER #
6399-57

6399-55P(817)
Product Made In U.S.A.

INGREDIENTS AND APPEARANCE

ALCARE PLUS FOAMED ANTISEPTIC HANDRUB 
alcohol aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-803
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)
ISOBUTANE (UNII: BXR49TP611)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYQUATERNIUM-6 (15000 MW) (UNII: YFL33X52PX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPANE (UNII: T75W9911L6)
SODIUM SESQUICARBONATE (UNII: Y1X815621J)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-803-76	62.4 g in 1 CAN; Type 0: Not a Combination Product	02/01/2018
2	NDC: 11084-803-57	153 g in 1 CAN; Type 0: Not a Combination Product	02/01/2018
3	NDC: 11084-803-36	255 g in 1 CAN; Type 0: Not a Combination Product	02/01/2018
4	NDC: 11084-803-80	482 g in 1 CAN; 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	part333E	02/01/2018

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Accra Pac, Inc.		024213616	MANUFACTURE(11084-803)