ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate solution 
AVA, Inc.

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Antiseptic Skin Cleanser
(Chlorhexidine Gluconate 4% Solution)

Drug Facts

Active ingredient

Chlorhexidine gluconate 4% solution

Purposes

surgical hand scrub
healthcare personnel handwash
patient preoperative skin preparation
skin wound and general skin cleansing

Uses

Warnings

For external use only

Do not use

  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • in contact with meninges
  • in the genital area
  • as a preoperative skin preparation of the head or face

When using this product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures 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
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population 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
  • scrub for 3 minutes with about 5 ml of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces
  • a separate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 ml of product and rinse under running water
  • 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 15 seconds
  • rinse and dry thoroughly

Patient preoperative skin preparation

  • apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
  • repeat procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and general skin cleansing

  • thoroughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
  • rinse again thoroughly

Other information

Inactive ingredients

fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions or comments?

Call 1-855-552-8274

Manufactured by:
AVA, Inc.
7051 S. Adams St.
Willowbrook, IL 60527

PRINCIPAL DISPLAY PANEL - 947 mL Bottle Label

NDC 42939-102-04

ANTISEPTIC SKIN CLEANSER

(Chlorhexidine Gluconate 4% Solution)

ANTISEPTIC/ANTIMICROBIAL SKIN CLEANSER

FOR EXTERNAL USE ONLY

32 fl.oz. (974 mL)

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

AVA Incorporated

Lot:

Exp:

PRINCIPAL DISPLAY PANEL - 947 mL Bottle Label

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42939-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLUCONOLACTONE 
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) 
ISOPROPYL ALCOHOL 
LAURAMINE OXIDE 
PEG-75 LANOLIN 
WATER 
TRIDECYL ALCOHOL 
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42939-102-04947 mL in 1 BOTTLE
2NDC:42939-102-03473 mL in 1 BOTTLE
3NDC:42939-102-02237 mL in 1 BOTTLE
4NDC:42939-102-01118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only12/06/2012
Labeler - AVA, Inc. (615317075)
Registrant - AVA, Inc. (615317075)
Establishment
NameAddressID/FEIBusiness Operations
AVA, Inc.615317075manufacture(42939-102)

Revised: 12/2012
Document Id: 5c4ecec7-868f-4ac0-a6e6-e48918a2536d
Set id: 76cfedb3-25ed-4c12-8ebc-b57f029fedaa
Version: 1
Effective Time: 20121206
 
AVA, Inc.