Other
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Xttrium Laboratories, Inc. for the product Bactoshield Chg (NDC 0116-1322). 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 2% 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 severe 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.
Surgical hand scrub:
Healthcare personnel handwash:
Patient preoperative skin preparation:
Skin wound and general skin cleansing:
citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water
Call 1-800-548-4873 Monday through Friday 8:00 AM to 4:30 PM CST
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
Dosage and Administration
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
* Please review the disclaimer below.