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- 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
DIRECTIONS FOR USE
REF 10404 – Dry Socket Paste – 1oz/28g
NPN Number: 02038641
See AlsoTreating Dry Socket: The Benefits of Dry Socket Paste | Bayview Blog9 Effective Solutions: Dry Socket Treatment at Home - KWC DentalDry Socket Explained: Managing Pain And Promoting HealingFor dental use only.
- 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.
- 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.comMade 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
- 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 0.0416g in1g EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL 0.0416g in1g 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)
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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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DRY SOCKET- guaiacol and eugenol paste
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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 |
