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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Xttrium Laboratories, Inc. for the product Bactoshield Chg (NDC 0116-1344). 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 other, active ingredient, purposes, uses, warnings, do not use, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
chlorhexidine gluconate 4% solution
surgical hand scrub
healthcare personnel handwash
patient preoperative skin preparation
skin wound and general skin cleansing
For external use only
Allergy alert:
This product may cause a sever allergic reaction. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stop use and ask a 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.
cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol
Call 1-800-548-4873 Monday through Friday 8:00 AM to 4:30 PM EST
WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Bactoshield ® CHG 4%
NDC 11084-815-03
Surgical Scrub
Chlorhexidine Cluconate 4% Solution Antiseptic
Non-sterile Solution
Surgical Scrub
4% CHG
Antimicrobial
For Single-Use
Net Contents: 118 mL (4 fl oz)
REORDER #1344-39
1344-52F(319)
61346
4BACT04BTLLBLD
Bactoshield ® CHG 4%
NDC 11084-815-34
Surgical Scrub
Chlorhexidine Gluconate 4% Solution Antiseptic
Surgical Scrub
4% CHG
Antimicrobial
Net Contents: 473mL (16 fl oz) (1 pt)
REORDER #1344-33
61340
1344-31H(319)
4BACT16BTLLBLE
Bactoshield ® CHG 4%
NDC 11084-815-24
Surgical Scrub
4% Solution Antiseptic Chlorhexidine Gluconate
Surgical Scrub
4% CHG
Antimicrobial
Net Contents: 32 fl oz (946 mL)
REORDER #1344-24
61341
1344-21H(319)
4BACT32BTLLBLB
Bactoshield ® CHG 4%
NDC 11084-815-08
Surgical Scrub
Chlorhexidine Gluconate 4% Solution Antiseptic
Surgical Scrub
4% CHG
Antimicrobial
Net Contents: 128 fl oz (1 Gal) (3.78 Liters)
REORDER #1344-08
1344-06G(319)
51690
4BACT1GLBLB
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