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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Drug Label Information
Updated January 26, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 1. DESCRIPTION
- 2. INDICATIONS
- 3. CONTRAINDICATIONS
- 4. PRECAUTIONS
- 5. WARNINGS
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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
- SPL UNCLASSIFIED SECTION
-
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
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INGREDIENTS AND APPEARANCE
DRY SOCKET
guaiacol and eugenol pasteProduct 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 Inactive Ingredients Ingredient Name Strength BALSAM PERU (UNII: 8P5F881OCY) CHLOROBUTANOL (UNII: HM4YQM8WRC) PETROLATUM (UNII: 4T6H12BN9U) YELLOW WAX (UNII: 2ZA36H0S2V) XANTHAN GUM (UNII: TTV12P4NEE) ACACIA (UNII: 5C5403N26O) 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 01/01/1963 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1963 Labeler - Dentsply LLC, Professional Division, trading as "Sultan Healthcare" (167087753) Establishment Name Address ID/FEI Business Operations Dentsply Caulk 083235549 MANUFACTURE(0699-0404)