Label: SCRUB, SCRUB-STAT, FOAM SAFE, MICRO-GUARD- chlorhexidine gluconate solution
- NDC Code(s): 42939-125-26
- Packager: AVA, Inc.
- This is a repackaged label.
- Source NDC Code(s): 47593-468
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 7, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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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 ingredient in this preparation
- as a patient preoperative 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 eardrums.
- if solution should contact these areas, rinse out promptly and thoroughly with water
- 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 advised by a healthcare provider
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Directions
- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
Surgical hand scrub:
- wet hands and forearms with water
- scrub for 3 minutes with 4 full pumps (about 5 mL) of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces
- a separate nail cleaner may be used
- rinse thoroughly with water
- wash for 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 4 full pumps (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 again thoroughly
- Other information
- Inactive ingredients
- Questions or comments?
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Representative label and principal display panel
Chlorhexidine Gluconate Liquid Foaming Solution
4%
Antiseptic Skin Cleanser
NDC 42939-125-26
4 fl oz (118 mL)
Non-Sterile.
For External Use only.
Manufactured by:
AVA Inc., Willowbrook IL 60527
Made in USAIssued: 07/2024.
Keep from freezing.
Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.
WARNING: This product can expose you to chemicals including amides, coco, n,n-bis(hydroxyethyl) and 2,2’-iminodiethanol which are known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.
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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:42939-125(NDC:47593-468) 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) 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:42939-125-26 118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019258 07/22/1986 Labeler - AVA, Inc. (615317075) Registrant - AVA, Inc. (615317075) Establishment Name Address ID/FEI Business Operations AVA, Inc. 615317075 analysis(42939-125) , api manufacture(42939-125) , manufacture(42939-125) , repack(42939-125)