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  5. Label Information: Dry Socket

FDA Label for Dry Socket

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. 1. DESCRIPTION
    3. 2. INDICATIONS
    4. 3. CONTRAINDICATIONS
    5. 4. PRECAUTIONS
    6. 5. WARNINGS
    7. 6. DOSAGE AND ADMINISTRATION
    8. 7. STORAGE
    9. PRINCIPAL DISPLAY PANEL

Dry Socket Product Label

The following document was submitted to the FDA by the labeler of this product Dentsply Llc, Professional Division, Trading As "sultan Healthcare". The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



DIRECTIONS FOR USE

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

NPN Number: 02038641

For dental use only.

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


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



  • 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.
  • Thoroughly rinse and de-bride the socket.
  • Introduce Dry Socket Paste into the socket using a flat-bladed instrument or a disposable syringe.
  • Tamp down the Dry Socket Paste, ensuring coverage of all exposed bone.
  • Do not cover the Dry Socket Paste.
  • 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.


* Please review the disclaimer below.