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

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4% Chlorhexidine Gluconate Solution
Product Code: 125
​​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*, 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, 24 hours a day, 7 days a week

Representative label and principal display panel

SCRUB ™

Chlorhexidine Gluconate 4% Foaming Solution

ANTIMICROBIAL SKIN CLEANSER

FOR EXTERNAL USE ONLY

www.SCRUBchg.com
AVA, Inc.
Willowbrook IL 60527

FDA APPROVED
MADE IN THE USA

WARNING: This product can expose you to cocamide DEA, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov

NDC 42939-125-19

32 fl oz (946 mL)

32

GREMED MEDICAL PRODUCTS

FOAM SAFE TM

Chlorhexidine Gluconate Liquid Solution

4.0%

ANTIMICROBIAL skin cleanser

FOR EXTERNAL USE ONLY

1 L (1.05 U.S Qt)

U.S. Patent No. Re 33,564

NDC 42939-125-23

GREMED.com

8040 NW 14 St

Doral FL 33126

(Bottle/Container Label)

gmdbtl

GREMED MEDICAL PRODUCTS

FOAM SAFE TM

Chlorhexidine Gluconate Liquid Solution

4.0%

ANTIMICROBIAL skin cleanser

FOR EXTERNAL USE ONLY

1 L (1.05 U.S Qt)

U.S. Patent No. Re 33,564

NDC 42939-125-23

GREMED.com

8040 NW 14 St

Doral FL 33126

(Case Label)

gmdcs

SCRUB, SCRUB-STAT, FOAM SAFE, MICRO-GUARD 
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42939-125(NDC:47593-468)
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)  
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:42939-125-19946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
2NDC:42939-125-2059 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
3NDC:42939-125-22236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
4NDC:42939-125-21118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
5NDC:42939-125-231000 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(42939-125) , api manufacture(42939-125) , manufacture(42939-125) , repack(42939-125)

Revised: 11/2023
Document Id: 09461c09-ae1a-f648-e063-6394a90ad893
Set id: 3e3d67c6-180c-1d9c-e054-00144ff8d46c
Version: 28
Effective Time: 20231103
 
AVA, Inc.