Dyna-hex
FDA Label NDC 67659-901

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Team Technologies, Inc for the product Dyna-hex (NDC 67659-901). 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 otc - active ingredient, purposes, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

 Chlorhexidine gluconate 2% Solution

Purposes

surgical hand scrub
healthcare personnel handwash
patient operative skin preparation
skin wound and general skin cleansing

Warnings

For external use only

Direction

  • use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.
  • 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 throughly 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 minutes
      • dry with sterile towel
      • repeat procedure for an additional 2 minutes and dry with sterile towel
      • Patient preoperative skin preparation:

        • apply product liberally to surgical site and swab for at least 2 minutes
        • dry with sterile towel
        • repeat procecedure for an additional 2 minutes and dry with sterile towel
        • Skin wound and general skin cleansing:

          • 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

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 1-800-587-3271 Monday through Friday 8:00 AM to 4:30 PM

Package Label

NDC 0116-1021-04

DYNA-HEX 2 ®

(Chlorhexidine Gluconate 2% Solution)

Antispeptic

Contains:  2% Chlorhexidine Gluconate

Distributed By: Xttrium Laboratories, Inc., Mount Prospect, IL 60056

For External Use Only.

Net Contents: 4 fl OZ (118 mL)

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