Antiseptic Skin Cleanser by Quality Choice / Xttrium Laboratories, Inc. / Xttirum Laboratories, Inc. QC 2%

Antiseptic Skin Cleanser by

Drug Labeling and Warnings

Antiseptic Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by Quality Choice, Xttrium Laboratories, Inc., Xttirum Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTISEPTIC SKIN CLEANSER EXIDINE-2 CHG- chlorhexidine gluconate solution 
Quality Choice

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QC 2%

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 reeamin 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 routinely 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

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 th coconut oill diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause sancer.

Package Label

NDC: 63868-280-02

Chlorhexidine Gluconate 2% Solution

Antiseptic

Distributed by:

C,D,M,A,Inc.

Novi, MI 48376 USA

qualitychoice.com

2QC02BTLLBL

Quality Choice ®

Net Wt 2 fl oz (60 mL)

2 PDP

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NDC: 63868-280-08

Chlorhexidine Gluconate 2% Solution

Antiseptic

Distributed by:

C,D,M,A,Inc.

Novi, MI 48376 USA

qualitychoice.com

2QC85BTLLBLBB

Quality Choice ®

Net Wt 8.5 fl oz (273 mL)

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Package Label... [ PACKAGE LABEL. SECONDARY DISPLAY PANNEL]

NDC: 63868-280-08

Chlorhexidine Gluconate 2% Solution

Antiseptic

Distributed by:

C,D,M,A,Inc.

Novi, MI 48376 USA

qualitychoice.com

2QC85BTLLBLFB

Quality Choice ®

Net Wt 8.5 fl oz (273 mL)

FL

ANTISEPTIC SKIN CLEANSER  EXIDINE-2 CHG
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63868-280
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63868-280-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/201602/29/2020
2NDC: 63868-280-08250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/201609/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01942207/01/201602/29/2020
Labeler - Quality Choice (011920774)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttirum Laboratories, Inc.007470579manufacture(63868-280)

Revised: 8/2019
 
Quality Choice