Scrub, Scrub-stat, Foam Safe, Micro-guard Solution
FDA Label NDC 42939-128

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ava, Inc. for the product Scrub, Scrub-stat, Foam Safe, Micro-guard (NDC 42939-128). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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

    • 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

Otc - 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

* Please review the disclaimer below.