Foam Safe

Germed Manufacturing LLC
Xttrium Laboratories, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredients
• Purpose
• Foam Safe Uses
• Warnings
  • Do not use
  • When using this product
  • Stop use and ask doctor if
  • Keep out of reach of children
• Directions
• Foam Safe Other information
• Inactive Ingredients
• Questions of comments?
• Package label and principal display panel

FULL PRESCRIBING INFORMATION

Active Ingredients

Chlorhexidine Gluconate 4% Solution

Purpose

surgical hand scurb

healthcare personel handwash

Foam Safe Uses

• surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
• healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

Warnings

For external use only.

Do not use

• if you are allergic to chlorhexidine gluconate or any other ingredients
• in contact with meninges
• in genital area
• as a preoperative skin preparation of the head or face

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 the underlying condition makes it necessary to reduce the bacterial population of skin

Stop use and ask doctor if

• irritation, sensitization, or allergic reaction occurs. 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 products may cause irritation or chemical burns.
Surgical hand scrub:

• wet hands and forearms with water
• scrub for 3 minutes with about 2.0 cubic inches (3 full strokes) 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
• wash for an additional 3 minutes with 2.0 cubic inches (3 full strokes) of product and rinse under running water
• dry thoroughly

Healthcare personnel handwash:

• wet hands with water
• dispense about 1.5 cubic inches (2 full strokes) of product into cupped hands and wash in a vigorous manner for 15 seconds and rinse under running water
• dry thoroughly

Foam Safe Other information

• store at 20°-25° C (68°-77° F)
• avoid excessive heat above 40° C (104° F)

Inactive Ingredients

cocamide DEA, fragrance, glucono-delta-lactone, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions of comments?

call 1-800-587-3721 Monday through Friday 8 AM to 4:30 PM CST

Package label and principal display panel

REF403
FOAM SAFE*
Chlorhexidine Gluconate 4% Solution Antiseptic

DISTRIBUTED BY
GREMED PRODUCTS, GREMED GROUP.
8880 NW 15TH St. MIAMI, FL 33172 USA

Registered trademark or trademark of Germed holdings

2008. All rights reserved.

Net Contents: 33.8 fl oz (1.05 qt) (1l)