Label: HYCLODEX-
- NHRIC Code(s): 00682-0048-1
- Packager: Marnel Pharmaceuticals, Inc.
- Category: PRESCRIPTION MEDICAL DEVICE LABEL
- DEA Schedule: None
- Marketing Status: Premarket Notification
Drug Label Information
Updated March 1, 2018
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INDICATIONS & USAGE
INDICATIONS FOR USE:
HyclodexTM Rx is intented to be used under the supervison of a health care professional for cleaning and removal of microorganisms, debris, and foreign material affecting various dermatologic skin conditions. Apply HyclodexTM solution liberally on site to clean. Do not remove or wipe off. If use of dressing is required, apply liberally to dressing. No rinsing is required.
- INFORMATION FOR OWNERS/CAREGIVERS
- INFORMATION FOR OWNERS/CAREGIVERS
- SUMMARY OF SAFETY AND EFFECTIVENESS
- CONTRAINDICATIONS
- INSTRUCTIONS FOR USE
- STORAGE AND HANDLING
- SAFE HANDLING WARNING
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WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS: For external use only. Do not use for infusion or injection. Do not swallow. If you experience redness, swelling, irritation or pain, discontinue use and contact your doctor. In case of sensitivities to chlorine, please exercise caution and consult with your doctor prior to use. Do not use expired product. Keep out of reach of children.
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYCLODEX
dressing, wound, drugProduct Information Product Type PRESCRIPTION MEDICAL DEVICE Item Code (Source) NHRIC:00682-0048 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:00682-0048-1 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date premarket notification K113693 02/26/2018 Labeler - Marnel Pharmaceuticals, Inc. (080161449)