FDA Label for Bactoshield Chg
View Indications, Usage & Precautions
Bactoshield Chg Product Label
The following document was submitted to the FDA by the labeler of this product Xttrium Laboratories, 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.
Other
Drug Facts
Active Ingredient
chlorhexidine gluconate 2% solution
Purposes
surgical hand scrub
healthcare personnel handwash
patient preoperative skin preparation
skin wound and general skin cleansing
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
- patient preoperative skin preparation: preparation of the patient's skin prior to surgery
- skin wound and general skin cleansing
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 or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
- in contact with meninges
- in the 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 advised by a health care provider
Otc - Stop Use
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. 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 products may cause irritation or chemical burns.
- wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
- scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers
- rinse thoroughly under the running water for 30 seconds
- wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
- dry thoroughly
- wet hands with water
- dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds
- rinse and dry thoroughly
- apply product liberally to surgical site and swab for at least 2 minutes
- dry with a sterile towel
- repeat procedure for an additional 2 minutes and dry with a sterile towel
- thoroughly rinse the area to e cleaned with water
- apply the minimum amount of product necessary to cover the skin or wound area and wash gently
- rinse again thoroughly
Surgical hand scrub:
Healthcare personnel handwash:
Patient preoperative skin preparation:
Skin wound and general skin cleansing:
Other Information
- store at 20 - 25°C (68 - 77°F)
- avoid excessive heat above 40°C (104°F)
Inactive Ingredients
citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water
Questions Or Comments?
Call 1-800-548-4873 Monday through Friday 8:00 AM to 4:30 PM CST
Other Safety Information
WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause. For more information go to www.P65Warnings.ca.gov
Recent Major Changes
Dosage and Administration
Package Label.Principal Display Panel
Bactoshield ® CHG 2%
NDC 11084-814-03
Surgical Scrub
Chlorhexidine Gluconate 2% Solution Antiseptic
Non-sterile Solution
Surgical Scrub
2% CHG
Antimicrobial
For Single-Use
Net Contents: 118 mL (4 fl oz)
1322-52G(319)
REORDER #1322-39
61345
2BACT04BTLLBLE
Bactoshield® CHG 2%
NDC 11084-814-24
Surgical Scrub
2% Solution Antiseptic
Chlorhexidine Gluconate
Surgical Scrub
2% CHG
Antimicrobial
Net Contents: 32 fl oz (946 mL)
REORDER #1322-24
61335
1322-21J(319)
2BACT32BTLLBLJ
Bactoshield ® CHG 2%
NDC 11084-814-08
Surgical Scrub
Chlorhexidine Gluconate 2% Solution Antiseptic
Surgical Scrub
2% CHG
Antimicrobial
Net Contents: 128 fl oz (1Gal)(3.78 Liters)
1322-06G(319)
REORDER #1322-08
62662
2BACT1GLBLB
NDC 11084-814-41
Bactoshield CHG 2%
Chlorhexidine Gluconate 2% Solution
Antiseptic
Healthcare Personnel Handwash
REORDER #: 1322-87
Manufactured for:
Deb USA, Inc.
Charlotte, NC 28217
1-866-783-0422
www.debmed.com
Contents: 33.8 fl oz (1.05 qt) (1 Liter)
61707
1322-86K (319)
SDSNATBKLBLA
NDC 11084-814-41
SDSNATFTLBLA
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