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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Xttrium Laboratories, Inc. for the product Dyna-hex (NDC 0116-1021). 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, purpose, 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
Antiseptic
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.
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:
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 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
Healthcare personnel handwash:
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
Patient preoperative skin preparation: (only on 4-oz)
apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
repeat procedure for an additional 2 minutes and dry with a sterile towel
Skin wound and general skin cleaning:
thoroughly rinse the area to be cleaned with water
apply the minimum amount of product necessary to cover the skin or wound area and wash gently
rinse again thoroughly
citric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water
call 1-800-587-3721
Monday through Friday 8:00 AM to 4:30 PM CST
NDC 0116-1021-04
Chlorhexidine Gluconate 2% Solution
Antiseptic Foam Handwash
Distributed by:
Xttrium Laboratories, Inc.
Mount Prospect, IL 60056
2BLDY04BTLLBLE
Dyna-Hex ®
Net Wt 4 fl oz (118 mL)
NDC 0116-1021-08
Chlorhexidine Gluconate 2% Solution
Antiseptic Foam Handwash
Distributed by:
Xttrium Laboratories, Inc.
Mount Prospect, IL 60056
2BLDY08BTLLBLB
Dyna-Hex ®
Net Wt 8 fl oz (237 mL)
* Please review the disclaimer below.