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  5. Label Information: Pre-scrub Ii Surgical Hand Scrub

FDA Label for Pre-scrub Ii Surgical Hand Scrub

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. WARNINGS
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. DOSAGE & ADMINISTRATION
    6. OTHER SAFETY INFORMATION
    7. INACTIVE INGREDIENT
    8. OTC - QUESTIONS
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pre-scrub Ii Surgical Hand Scrub Product Label

The following document was submitted to the FDA by the labeler of this product Biomed Systems, 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.

Otc - Active Ingredient



Active Ingredient

Chlorhexidine Gluconate 4% Solution


Indications & Usage



Uses

• surgical hand scrub: significantly reduces the number of micro-

organisms on the hands and forearms prior to surgery or patient care


Warnings



Error

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.


Dosage & Administration



Directions

• Use with care in Premature infants under 2 months of age. These

products may cause irritation or chemical burns.

• open package

• wet hands and forearms to the elbows with warm water

• clean under nails with nail pick provided. Nails should be maintained

with a 1 millimeter free edge

• wet sponge and squeeze to work up lather

• scrub thoroughly for 3 minutes. Paying particular attention to the

nails, cuticles and interdigital spaces. Use the brush side to clean the

nails, cuticles and interdigital spaces between the fingers and the

sponge side to scrub the hands and forearms

• rinse thoroughly with warm water

• scrub for an additional 3 minutes using the sponge side

• discard brush-sponge

• rinse hands and forearms thoroughly and dry with a sterile towel.


Other Safety Information



Other information

• store between 20-25°C (68-77°F)

•avoid freezing and excessive heat 40°C (104°F}


Inactive Ingredient



Inactive ingredientscocamide DEA, fragrance POFL 147, glucono-delta-lactone, isopropyl alcohol 4%, lauramine oxide, PEG-75 lanolin, purified water, USP, tridecyl alcohol


Otc - Questions



Questions? 800-424-5556 (Monday to Friday 8 AM – 5 PM)


Package Label.Principal Display Panel




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