Label: DRY SOCKET- guaiacol and eugenol paste

  • NDC Code(s): 0699-0404-01
  • Packager: Dentsply LLC, Professional Division, trading as "Sultan Healthcare"
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 17, 2015

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    DIRECTIONS FOR USE

    REF 10404 – Dry Socket Paste – 1oz/28g

    NPN Number: 02038641

    For dental use only.

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  • 1. DESCRIPTION

    Dry Socket Paste is formulated relieve the symptoms of alveolar osteitis ("dry socket syndrome"). Dry Socket Paste contains 4% guaicol and 4% eugenol in a petrolatum base.

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  • 2. INDICATIONS

    Indicated for the relief of symptoms associated with post-extraction alveolar osteitis ("dry socket syndrome").

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  • 3. CONTRAINDICATIONS

    This product should not be used with individuals with known sensitivities to guaicol or eugenol. This product should not be used with individuals who are pregnant or suspected to be pregnant without a prior physician consultation.

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  • 4. PRECAUTIONS

    For professional dental use only. Use only as directed. Not for unsupervised home use.

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  • 5. WARNINGS

    Do not swallow. Keep out of reach of children. For professional dental use only.

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  • 6. DOSAGE AND ADMINISTRATION

    1. Establish a diagnosis of alveolar osteitis; typically characterized as a constant dull or throbbing ache, exacerbated by touch, approximately 2 days post extraction. The socket will have no clot present and will usually be packed with food debris.
    2. Thoroughly rinse and de-bride the socket.
    3. Introduce Dry Socket Paste into the socket using a flat-bladed instrument or a disposable syringe.
    4. Tamp down the Dry Socket Paste, ensuring coverage of all exposed bone.
    5. Do not cover the Dry Socket Paste.
    6. Dry Socket Paste will remain in the extraction socket 3 to 5 days and will gradually wash out as the socket heals – there is no need for a separate visit to remove the product.
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  • 7. STORAGE

    Store between 59°-86°F (15°-30°C). Protect from freezing.

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  • SPL UNCLASSIFIED SECTION

    Sultan Healthcare
    1301 Smile Way • York, PA 17404-0807 • USA
    Toll Free: 800-637-8582 • Phone: 201-871-1232
    Fax: 201-871-0321 • www.sultanhealthcare.com

    Made in the USA
    0010404DF, R1-080714

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  • PRINCIPAL DISPLAY PANEL - 28 g Jar Label

    Dry Socket Paste

    Net Contents: 1oz (28gm)

    DIRECTIONS FOR USE: Fill socket with paste. Be sure to cover all exposed bone.

    ACTIVE INGREDIENTS: Guaiacol 4.16%, Eugenol 4.16%.

    CAUTION: DO NOT TAKE INTERNALLY

    0010404LA, R1-080714

    PRINCIPAL DISPLAY PANEL - 28 g Jar Label
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  • INGREDIENTS AND APPEARANCE
    DRY SOCKET 
    guaiacol and eugenol paste
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0404
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaiacol (UNII: 6JKA7MAH9C) (Guaiacol - UNII:6JKA7MAH9C) Guaiacol 0.0416 g  in 1 g
    Eugenol (UNII: 3T8H1794QW) (Eugenol - UNII:3T8H1794QW) Eugenol 0.0416 g  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0699-0404-01 28 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 01/01/1900
    Labeler - Dentsply LLC, Professional Division, trading as "Sultan Healthcare" (167087753)
    Establishment
    Name Address ID/FEI Business Operations
    DENTSPLY Caulk 083235549 MANUFACTURE(0699-0404)
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