SCRUB CARE EXIDINE-2 CHG- chlorhexidine gluconate solution

Scrub Care by

Drug Labeling and Warnings

Scrub Care by is a Otc medication manufactured, distributed, or labeled by Xttrium Laboratories, Inc., Xttirum Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

chlorhexidine gluconate 2% solution

Purpose

Antiseptic

Uses

• surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
• healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

• wheezing/difficulty breathing
• shock
• facial swelling
• hives
• rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

• if you are allergic to chlorhexidine gluconate or any other ingredient in this product

When using this product

• keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums.
• if solution should contact these areas, rinse out promptly and thoroughly with water
• do not use rooutinely if you have wounds which involve more than the superficial layers of the skin

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Surgical hand scrub:

• wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
• scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers
• rinse thoroughly under running water for 30 seconds
• wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
• dry thoroughly

Healthcare personnel handwash:

• wet hands with water
• dispense about 5 mL of product into cupped hands and wash in a vigorous manner for about 15 seconds
• rinse and dry thoroughly

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
  

Inactive ingredients

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

Call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM

OTHER SAFETY INFORMATION

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.

Warning: This product can expose you to cocnut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

Package Label

CVS Health

NDC: 59779-722-75

Advanced Antimicrobial Hand Soap

CHLORHEXIDINE GLUCONATE 2% SOLUTION

Antiseptic/Antimicrobial skin cleanser

• Used by healthcare professionals
• Clinically proven to reduce bacteria on the skin
• Paraben & phthalate free

8.5 FL OZ (250 mL)

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2CVS85LBLBA

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INGREDIENTS AND APPEARANCE

SCRUB CARE  EXIDINE-2 CHG
chlorhexidine gluconate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0116-0722
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-0722-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2015	02/28/2018
2	NDC: 0116-0722-75	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019422	12/01/2015

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttirum Laboratories, Inc.		007470579	manufacture(0116-0722)