SCRUB, SCRUB-STAT, FOAM SAFE, MICRO-GUARD- chlorhexidine gluconate solution 
AVA, Inc.

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4% Chlorhexidine Gluconate Liquid Solution
Product Code: 128
​​AVA, Inc.

Active ingredient

Chlorhexidine gluconate, 4%

Purposes

Surgical hand scrub

Healthcare personnel handwash

Skin wound and general skin cleanser

Uses

Warnings

For external use only

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

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 ingredients in this preparation
  • as a properative skin preparation (especially on the head or face)
  • in contact with meninges
  • in the genital area

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 during surgical procedures or may cause deafness when instilled in the middle ear through perforated ear drums.
  • if contact occurs, rinse with cold water right away
  • 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 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 and lasts for 72 hours. 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

Surgical hand scrub

Healthcare personnel handwash

Skin wound and general skin cleanser

Other information

Inactive ingredients

cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, hydroxyethylcellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water

*contains one or more of these ingredients

Questions or comments?

Call 1-800-581-2528 Monday through Friday 8:00 AM to 5:00 PM CT.

Representative label and principal display panel

Chlorhexidine Gluconate Liquid Solution

4%

NDC 42939-128-01

Antiseptic Skin Cleanser

4 fl oz (118 mL)

Non-Sterile.

For External Use only.

1234

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

WARNING: This product can expose you to chemicals including amides, coco, n,n-bis(hydroxyethyl) and 2,2’-iminodiethanol which are known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.

Keep from freezing.

Revised: 08/2023

Manufactured by:

AVA Inc., Willowbrook IL 60527

Made in USA

SCRUB, SCRUB-STAT, FOAM SAFE, MICRO-GUARD 
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42939-128(NDC:47593-464)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
COCAMINE OXIDE (UNII: QWA2IZI6FI)  
GLUCONIC ACID (UNII: R4R8J0Q44B)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
QUATERNIUM-33 (UNII: XPS4174QZJ)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42939-128-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
2NDC:42939-128-02540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
3NDC:42939-128-03750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/22/1986
4NDC:42939-128-04750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
5NDC:42939-128-05800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
6NDC:42939-128-06946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
7NDC:42939-128-07946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
8NDC:42939-128-081000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
9NDC:42939-128-091000 mL in 1 POUCH; Type 0: Not a Combination Product07/22/1986
10NDC:42939-128-101250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
11NDC:42939-128-111250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/22/1986
12NDC:42939-128-123785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
13NDC:42939-128-1330 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
14NDC:42939-128-1459 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
15NDC:42939-128-15118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
16NDC:42939-128-16236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
17NDC:42939-128-17236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
18NDC:42939-128-18473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
19NDC:42939-128-19946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
20NDC:42939-128-2059 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
21NDC:42939-128-21118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
22NDC:42939-128-22236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
23NDC:42939-128-231000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01925807/22/1986
Labeler - AVA, Inc. (615317075)
Establishment
NameAddressID/FEIBusiness Operations
AVA, Inc.615317075analysis(42939-128) , api manufacture(42939-128) , manufacture(42939-128) , repack(42939-128)

Revised: 5/2024
Document Id: 1784059d-58a1-236a-e063-6394a90aa2cb
Set id: 3e3c8e79-230e-4dd3-e054-00144ff88e88
Version: 30
Effective Time: 20240502
 
AVA, Inc.