DailyMed - DRY SOCKET- guaiacol and eugenol paste (2024)

  • Label RSS
  • 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

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Drug Label Information

Updated January 26, 2024

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

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  • SPL UNCLASSIFIED SECTION
  • 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.

  • 2. INDICATIONS

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

  • 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.

  • 4. PRECAUTIONS

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

  • 5. WARNINGS

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

  • 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.
  • 7. STORAGE

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

  • 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

  • Principal DIsplay Panel

    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

    REF 10404

    NPN 02038641

    Made in USA

    Manufactured for:

    Sultan Healthcare

    1301 Smile Way • York, PA 17404-0807

    Toll Free: 800-637-8582 • Phone: 201-871-1232

    Fax: 201-871-0321 • www.sultanhealthcare.com

    In Canada Imp. By VDI Healthcare, Brampton, Ontario L6W 4T5

    DailyMed - DRY SOCKET- guaiacol and eugenol paste (2)

  • INGREDIENTS AND APPEARANCE
    DRY SOCKET
    guaiacol and eugenol paste
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-0404
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIACOL (UNII: 6JKA7MAH9C) (GUAIACOL - UNII:6JKA7MAH9C) GUAIACOL0.0416g in1g
    EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL0.0416g in1g
    Inactive Ingredients
    Ingredient NameStrength
    BALSAM PERU (UNII: 8P5F881OCY)
    CHLOROBUTANOL (UNII: HM4YQM8WRC)
    PETROLATUM (UNII: 4T6H12BN9U)
    YELLOW WAX (UNII: 2ZA36H0S2V)
    XANTHAN GUM (UNII: TTV12P4NEE)
    ACACIA (UNII: 5C5403N26O)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-0404-0128 g in 1 JAR; Type 0: Not a Combination Product01/01/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/01/1963

    Labeler -Dentsply LLC, Professional Division, trading as "Sultan Healthcare"(167087753)

    Establishment
    NameAddressID/FEIBusiness Operations
    Dentsply Caulk083235549MANUFACTURE(0699-0404)

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DRY SOCKET- guaiacol and eugenol paste

Number of versions: 4

Published Date (What is this?) Version Files
Jan 29, 2024 4 (current) download
Jan 20, 2022 3 download
Dec 22, 2017 2 download
Oct 6, 2015 1 download

RxNorm

DRY SOCKET- guaiacol and eugenol paste

RxCUI RxNorm NAME RxTTY
1 1673047 guaiacol 4.16 % / eugenol 4.16 % Oral Ointment PSN
2 1673047 eugenol 0.041 MG/MG / guaiacol 0.041 MG/MG Oral Ointment SCD
3 1673047 eugenol 4.16 % / guaiacol 4.16 % Dental Paste SY
4 1673047 eugenol 4.16 % / guaiacol 4.16 % Oral Ointment SY

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NDC Codes

DRY SOCKET- guaiacol and eugenol paste

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1 0699-0404-01
DailyMed - DRY SOCKET- guaiacol and eugenol paste (2024)
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