PRE-SCRUB II SURGICAL HAND SCRUB- chlorhexidine gluconate solution solution 
BioMed Systems, Inc.

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Pre-Scrub II Surgical Hand Scrub

Active Ingredient

Chlorhexidine gluconate 4% Solution

Purpose

Antiseptic

Uses

surgical hand scrub: significantly reduces the number of micro-

organisms on the hands and forearms prior to surgery or patient care

Warnings

For external use only

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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.

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Do not use

product

____________________________________________________________________

When using this product

if permitted to enter or allowed to remain.

layers of the skin

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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.

• open package

• wet hands and forearms to the elbows with warm water

• clean under nails with nail pick provided. Nails should be maintained

with a 1 millimeter free edge

• wet sponge and squeeze to work up lather

• scrub thoroughly for 3 minutes. Paying particular attention to the

nails, cuticles and interdigital spaces. Use the brush side to clean the

nails, cuticles and interdigital spaces between the fingers and the

sponge side to scrub the hands and forearms

• rinse thoroughly with warm water

• scrub for an additional 3 minutes using the sponge side

• discard brush-sponge

• rinse hands and forearms thoroughly and dry with a sterile towel.

Other information

• store between 20-25ºC (68-77ºF)

•avoid freezing and excessive heat 40ºC (104ºF}

Inactive ingredientscocamide DEA, fragrance POFL 147, glucono-delta-lactone, isopropyl alcohol 4%, lauramine oxide, PEG-75 lanolin, purified water, USP, tridecyl alcohol

Questions? 800-424-5556 (Monday to Friday 8 AM – 5 PM)

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PRE-SCRUB II  SURGICAL HAND SCRUB
chlorhexidine gluconate solution solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22884-8103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE1 mg  in 25 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
LANOLIN (UNII: 7EV65EAW6H)  
WATER (UNII: 059QF0KO0R)  
TRIDECYL ALCOHOL (UNII: 8I9428H868)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22884-8103-830 in 1 CARTON03/01/1989
1NDC:22884-8103-125 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01982203/01/1989
Labeler - BioMed Systems, Inc. (622463388)
Registrant - K. W. Griffen Company (622463388)
Establishment
NameAddressID/FEIBusiness Operations
Bajaj Medical LLC078774921manufacture(22884-8103)
Establishment
NameAddressID/FEIBusiness Operations
BioMed Systems622463388relabel(22884-8103) , repack(22884-8103)

Revised: 12/2021
Document Id: d2d127e3-ed4c-1708-e053-2a95a90af14f
Set id: 1a2028e1-4c3c-4c94-b0a4-7eb6e273f60e
Version: 3
Effective Time: 20211228
 
BioMed Systems, Inc.