SCRUB, SCRUB-STAT- chlorhexidine gluconate solution 
Bajaj Medical, LLC

----------

Drug Facts

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:

  • 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 ingredients in this preparation
  • as a patient 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 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 immediately

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 +1.773.657.4777, 24 hours a day, 7 days a week

Representative label and principal display panel

Label

SCRUB, SCRUB-STAT 
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61037-421
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
COCAMINE OXIDE (UNII: QWA2IZI6FI)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
GLUCONIC ACID (UNII: R4R8J0Q44B)  
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
QUATERNIUM-33 (UNII: XPS4174QZJ)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61037-421-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
2NDC:61037-421-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
3NDC:61037-421-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
4NDC:61037-421-04473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
5NDC:61037-421-05473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/22/1986
6NDC:61037-421-06946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
7NDC:61037-421-07946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/22/1986
8NDC:61037-421-083785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
9NDC:61037-421-09237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/22/1986
10NDC:61037-421-10118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
11NDC:61037-421-11540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
12NDC:61037-421-12750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/22/1986
13NDC:61037-421-13750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
14NDC:61037-421-1459 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
15NDC:61037-421-15800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
16NDC:61037-421-16946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
17NDC:61037-421-17946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/22/1986
18NDC:61037-421-181000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
19NDC:61037-421-191000 mL in 1 POUCH; Type 0: Not a Combination Product07/22/1986
20NDC:61037-421-201250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
21NDC:61037-421-211250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/22/1986
22NDC:61037-421-2230 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
23NDC:61037-421-2359 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/1986
24NDC:61037-421-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/1986
25NDC:61037-421-25237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/22/1986
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01925807/22/1986
Labeler - Bajaj Medical, LLC (078774921)
Registrant - Bajaj Medical, LLC (078774921)
Establishment
NameAddressID/FEIBusiness Operations
Bajaj Medical, LLC078774921analysis(61037-421) , manufacture(61037-421) , relabel(61037-421) , repack(61037-421)

Revised: 7/2016
Document Id: 4be6ce23-e722-510e-e054-00144ff8d46c
Set id: 4be6ce23-e721-510e-e054-00144ff8d46c
Version: 11
Effective Time: 20160711
 
Bajaj Medical, LLC