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
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Updated June 17, 2015
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- SPL UNCLASSIFIED SECTION
DIRECTIONS FOR USE
REF 10404 – Dry Socket Paste – 1oz/28g
NPN Number: 02038641
For dental use only.Close
- 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.Close
- 2. INDICATIONS
Indicated for the relief of symptoms associated with post-extraction alveolar osteitis ("dry socket syndrome").Close
- 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.Close
- 4. PRECAUTIONS
For professional dental use only. Use only as directed. Not for unsupervised home use.Close
- 5. WARNINGS
Do not swallow. Keep out of reach of children. For professional dental use only.Close
- 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.Close
- SPL UNCLASSIFIED SECTION
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 USAClose
- 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
- INGREDIENTS AND APPEARANCE
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)