PRE-SCRUB II SURGICAL HAND SCRUB- chlorhexidine gluconate solution solution

Pre-Scrub II by

Drug Labeling and Warnings

Pre-Scrub II by is a Otc medication manufactured, distributed, or labeled by BioMed Systems, Inc., K. W. Griffen Company, Bajaj Medical LLC, BioMed Systems. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Chlorhexidine gluconate 4% Solution

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

surgical hand scrub: significantly reduces the number of micro-

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

WARNINGS

Warnings

For external use only

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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.

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Do not use

• If you are allergic to chlorhexidine gluconate or any other ingredient in this

product

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When using this product

• keep out of eyes, ears, and mouth. May cause serious and permanent eye injury

if permitted to enter or allowed to remain.

• if contact occurs, rinse with cold water right away
• do not use routinely if you have wounds which involve more thank the superficial

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

store between 20-25ºC (68-77ºF)

avoid freezing and excessive heat 40ºC (104ºF}

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRE-SCRUB II  SURGICAL HAND SCRUB
chlorhexidine gluconate solution solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22884-8103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	1 mg  in 25 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22884-8103-8	30 in 1 CARTON	03/01/1989
1	NDC: 22884-8103-1	25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019822	03/01/1989

Labeler - BioMed Systems, Inc. (622463388)

Registrant - K. W. Griffen Company (622463388)

Establishment
Name	Address	ID/FEI	Business Operations
BioMed Systems		622463388	relabel(22884-8103) , repack(22884-8103)