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%
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.
Otc - 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.
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
- 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
- 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
- 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
Surgical hand scrub
Healthcare personnel handwash
Skin wound and general skin cleanser
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
Otc - Questions
Questions? call 1-630-570-0783, Monday through Friday, 8:30 AM to 4:30 PM CT
Inactive Ingredient
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
Representative Label And Principal Display Panel
AVA, Inc.
NDC 42939-124-12
SCRUB ™
Chlorhexidine Gluconate 2% Liquid 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
* Please review the disclaimer below.