Antimicrobial Skin Cleanser: Package Insert and Label Information

ANTIMICROBIAL SKIN CLEANSER- chlorhexidine gluconate liquid
Gojo Industries, Inc.

Drug Facts

Active ingredient

Chlorhexidine gluconate 2% solution

Purpose

Antiseptic

Uses

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

Warnings

For external use only

Allergy alert:

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

  • wheezing/difficulty breathting
  • 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 permenant eye injury if permitted to enter and remain in the eye or may cause deafness when instilled through 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 under 2 months of age. These products may cause irritation or chemical burns.

Healthcare personnel handwash:

  • wet hands with water
  • dispense 5 mL of product (4 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds
  • dry thoroughly

Surgical hand scrub:

  • wet hands and forearms with water
  • scrub for 3 minutes with 5 mL of product (4 full strokes), with a wet brush, paying close attention to the nails, cuticles, and skin between the fingers
  • a seperate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 mL of product (4 full strokes) and rinse under running water and dry thoroughly
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat about 40ºC (104ºF)

Inactive ingredients

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

Questions or comments?

call 1-800-321-9647 Monday through Friday 8:30 AM to 5:00 PM

NDC 21749-106-89

Chlorhexidine Gluconate 2% Solution

Antimicrobial SKin Cleanser

Distributed by:

Gojo Industries, Inc.

Akron, OH 44309

330-255-6000

www.gojo.com

FMX
(click image for full-size original)

NDC 21749-106-89

Chlorhexidine Gluconate 2% Solution

Antimicrobial SKin Cleanser

Distributed by:

Gojo Industries, Inc.

Akron, OH 44309

330-255-6000

www.gojo.com

TFX
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Back GOJO 1
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Back GOJO 2
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Back GOJO 3
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NDC 21749-106-32

PROVON BRAND

Antimicrobial Skin Cleanser

Chlorhexidine Gluconate

2% Solution

Antiseptic

Distributed by:

GOJO Industries, Inc.

Akron, OH 44309

Questions?

Tel. 800-321-9647

*330-255-6000

www.GOJO.com

©2018. All rights reserved.

2PROV32BTLLBL

4104-12

Net Contents: 32 fl oz (1qt) (946 mL)

PROV32 PDP
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PROV32 Drug Facts 1
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PROV32 Drug Facts 2
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ANTIMICROBIAL SKIN CLEANSER
chlorhexidine gluconate 2% solution liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21749-106
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CITRIC ACID MONOHYDRATE
COCO DIETHANOLAMIDE
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
ISOPROPYL ALCOHOL
LAURAMINE OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21749-106-89 1200 mL in 1 BOTTLE None
2 NDC:21749-106-32 946 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019422 03/01/2008
Labeler — Gojo Industries, Inc. (004162038)
Registrant — Xttrium Laboratories, Inc. (007470579)
Establishment
Name Address ID/FEI Operations
Xttrium Laboratories, Inc. 007470579 manufacture (21749-106)

Revised: 06/2019 Gojo Industries, Inc.

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