Label: SCRUB, SCRUB-STAT, FOAM SAFE, MICRO-GUARD- chlorhexidine gluconate solution
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NDC Code(s):
42939-124-19,
42939-124-20,
42939-124-21,
42939-124-22, view more42939-124-23
- Packager: AVA, Inc.
- This is a repackaged label.
- Source NDC Code(s): 47593-467
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 3, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purposes
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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
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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 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
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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
- Inactive ingredients
- Questions or comments?
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Representative label and principal display panel
SCRUB™
Chlorhexidine Gluconate 2% Foaming Solution
ANTIMICROBIAL SKIN CLEANSER
FOR EXTERNAL USE ONLY
www.SCRUBchg.com
AVA, Inc.
Willowbrook IL 60527FDA APPROVED
MADE IN THE USAWARNING: 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 42939-124-19
32 fl oz (946 mL)
GREMED MEDICAL PRODUCTS
FOAM SAFE TM
Chlorhexidine Gluconate Liquid Solution
2.0%
ANTIMICROBIAL skin cleanser
FOR EXTERNAL USE ONLY
1 L (1.05 U.S Qt)
U.S. Patent No. Re 33,564
NDC 42939-124-23
GREMED.com
8040 NW 14 St
Doral FL 33126
(Bottle/Container Label)
GREMED MEDICAL PRODUCTS
FOAM SAFE TM
Chlorhexidine Gluconate Liquid Solution
2.0%
ANTIMICROBIAL skin cleanser
FOR EXTERNAL USE ONLY
1 L (1.05 U.S Qt)
U.S. Patent No. Re 33,564
NDC 42939-124-23
GREMED.com
8040 NW 14 St
Doral FL 33126
(CASE LABEL)
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INGREDIENTS AND APPEARANCE
SCRUB, SCRUB-STAT, FOAM SAFE, MICRO-GUARD
chlorhexidine gluconate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42939-124(NDC:47593-467) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:42939-124-19 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/1986 2 NDC:42939-124-20 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/1986 3 NDC:42939-124-21 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/1986 4 NDC:42939-124-22 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/1986 5 NDC:42939-124-23 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(42939-124) , api manufacture(42939-124) , manufacture(42939-124) , repack(42939-124)