Label: KERAGEL- glycerin
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NHRIC Code(s):
71474-301-20,
71474-301-10,
71474-301-30,
71474-301-55, view more71474-301-05
- Packager: MOLECULAR BIOLOGICALS, LLC
- Category: PRESCRIPTION MEDICAL DEVICE LABEL
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated September 26, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Description
- INDICATIONS FOR USE
- ATTENTION
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DIRECTIONS FOR USE
- Cleanse and debride the wound in accordance with normal procedures.
- Ensure that the skin surrounding the wound is dry.
- The tube is opened using the piercer cap to break the nozzle seal. To ensure sterility, sanitise the piercer cap before using.
- Apply a 3mm to 6mm (1/8inch to 1/4inch) layer of keragel® to cover the entire wound surface.
- Cover with an appropriate secondary dressing if needed.
- RECOMMENDED CARE
- INGREDIENTS
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HOW SUPPLIED
keragel® 20gm individual tube: NDC 71474-301-20 keragel 5 gm individual tube: NDC 71474-301-05 STORAGE / PRECAUTIONS
keragel® should be stored in dry conditions between 0° and 35°C (32° and 95° F).
Do not use if the tube has been damaged prior to use. Sterility is guaranteed until the tube is first opened. Do not re-sterilise.
CAUTION: RX ONLY. Federal law restricts this device to sale by or on the order of a physician.
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SPL UNCLASSIFIED SECTION
Manufactured for: Molecular Biologicals, LLC
Pasadena, TX 77505 | 1-844-793-9933EC REP Keraplast Research Limited, Gerald St., Lincoln 7674, NZ
Medical Device Consultancy, 7 Pinewood Drive, Ashley Heath,
Market Drayton, Shropshire TF9 4PA, United KingdomkeragelT® is a registered trademark of
Keraplast Technologies LLC.
The product incorporates patented and/or patent pending
technologies owned by Keraplast Technologies LLC.Issue Date 8/2017
DWG106/1 - PRINCIPAL DISPLAY PANEL - 5 g Tube Box
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INGREDIENTS AND APPEARANCE
KERAGEL
dressing, wound, drugProduct Information Product Type PRESCRIPTION MEDICAL DEVICE Item Code (Source) NHRIC:71474-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin 100 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:71474-301-20 1 in 1 BOX 1 20 g in 1 TUBE; Type 0: Not a Combination Product 2 NHRIC:71474-301-10 10 in 1 BOX 2 20 g in 1 TUBE; Type 0: Not a Combination Product 3 NHRIC:71474-301-30 30 in 1 BOX 3 20 g in 1 TUBE; Type 0: Not a Combination Product 4 NHRIC:71474-301-55 5 in 1 BOX 4 20 g in 1 TUBE; Type 0: Not a Combination Product 5 NHRIC:71474-301-05 1 in 1 BOX 5 5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date EXEMPT DEVICE FRO 02/11/2009 Labeler - MOLECULAR BIOLOGICALS, LLC (079518915)