SCRUB, SCRUB-STAT, FOAM SAFE, MICRO-GUARD- chlorhexidine gluconate solution

Scrub, Scrub-Stat, Foam Safe, Micro-Guard by

Drug Labeling and Warnings

Scrub, Scrub-Stat, Foam Safe, Micro-Guard by is a Otc medication manufactured, distributed, or labeled by AVA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chlorhexidine gluconate, 4%

Purpose

Surgical hand scrub

Healthcare personnel handwash

Skin wound and general skin cleanser

Uses

• surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
• healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease
• skin wound and general cleanser: helps reduce bacteria on the skin

Warnings

For external use only

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

• use with care in premature infants or infants under 2 months of age. These product may cause irritation or chemical burns.
• use full strength
• do not dilute

Surgical hand scrub

• remove jewelry
• wet hands and forearms with water and apply 5 mL of the product
• wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
• rinse thoroughly with water
• washfor an additional 3 minutes with 5 mL of the product and rinse under running water
• dry thoroughly

Healthcare personnel handwash

• wet hands with water
• dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds
• rinse and dry thoroughly

Skin wound and general skin cleanser

• thoroughly rinse the area to be cleansed with water
• apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water.
• rinse again thoroughly

Other information

• store between 20-25 °C (68-77 °F)
• avoid excessive heat (above 104 °F/40 °C)
• for additional information, see Material Safety Data Sheet (MSDS)
• if swallowed get medical help or contact a Poison Control Center immediately

INACTIVE INGREDIENT

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

Questions? call 1-630-570-0783, Monday through Friday, 8:30 AM to 4:30 PM CT

Representative label and principal display panel

AVA, Inc.

NDC: 42939-128-12

SCRUB ™

Chlorhexidine Gluconate 4% Foaming Solution

Surgical Hand Scrub, Healthcare Personnel Handwash, and Skin Wound and General Skin Cleanser

Net Content: 1 Gallon (3785 mL)

WARNING! This product contains a chemical known in the

State of California to cause cancer.

KEEP FROM FREEZING

www.SCRUBchg.com

AVA, Inc.

7051 South Adams Street

Willowbrook, IL 60527-7592

INGREDIENTS AND APPEARANCE

SCRUB, SCRUB-STAT, FOAM SAFE, MICRO-GUARD 
chlorhexidine gluconate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42939-128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42939-128-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/1986
2	NDC: 42939-128-02	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/1986
3	NDC: 42939-128-03	750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/22/1986
4	NDC: 42939-128-04	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/1986
5	NDC: 42939-128-05	800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/1986
6	NDC: 42939-128-06	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986
7	NDC: 42939-128-07	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986
8	NDC: 42939-128-08	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/1986
9	NDC: 42939-128-09	1000 mL in 1 POUCH; Type 0: Not a Combination Product	07/22/1986
10	NDC: 42939-128-10	1250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986
11	NDC: 42939-128-11	1250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/22/1986
12	NDC: 42939-128-12	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/1986
13	NDC: 42939-128-13	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986
14	NDC: 42939-128-14	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986
15	NDC: 42939-128-15	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986
16	NDC: 42939-128-16	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986
17	NDC: 42939-128-17	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986
18	NDC: 42939-128-18	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986
19	NDC: 42939-128-19	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986
20	NDC: 42939-128-20	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986
21	NDC: 42939-128-21	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986
22	NDC: 42939-128-22	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986
23	NDC: 42939-128-23	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/1986

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019258	07/22/1986

Labeler - AVA, Inc. (615317075)

Establishment
Name	Address	ID/FEI	Business Operations
AVA, Inc.		615317075	analysis(42939-128) , api manufacture(42939-128) , manufacture(42939-128) , repack(42939-128)