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.
Updated November 27, 2017
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- 1. DESCRIPTION
- 2. INDICATIONS
- 3. CONTRAINDICATIONS
- 4. PRECAUTIONS
- 5. WARNINGS
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
Made in USA
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
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 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 01/01/1900 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)