FDA Label for Scrub, Scrub-stat, Foam Safe, Micro-guard

View Indications, Usage & Precautions

Scrub, Scrub-stat, Foam Safe, Micro-guard Product Label

The following document was submitted to the FDA by the labeler of this product Ava, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Chlorhexidine gluconate, 2%


Purposes



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

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

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 Ingredients



cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water

*contains one or more of these ingredients


Questions Or Comments?



call 1.800.581.2528, 24 hours a day, 7 days a week


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 60527

FDA APPROVED

MADE IN THE USA

WARNING: 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 42939-124-01

4 fl oz (118 mL)

NDC 42939-124-17

8 fl oz (236 mL)

NDC 42939-124-18

16 fl oz (473 mL)

NDC 42939-124-12

128 fl oz (3785 mL)


* Please review the disclaimer below.