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NDC 00699-0404-01 Dry Socket .0416; .0416 g/g; g/g Details
Dry Socket .0416; .0416 g/g; g/g
Dry Socket is a DENTAL PASTE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dentsply LLC, Professional Division, trading as "Sultan Healthcare". The primary component is EUGENOL; GUAIACOL.
Product Information
| NDC | 00699-0404 |
|---|---|
| Product ID | 0699-0404_4e832f3c-e9b8-4016-97d8-29660f8720e8 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Dry Socket |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaiacol and Eugenol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | PASTE |
| Route | DENTAL |
| Active Ingredient Strength | .0416; .0416 |
| Active Ingredient Units | g/g; g/g |
| Substance Name | EUGENOL; GUAIACOL |
| Labeler Name | Dentsply LLC, Professional Division, trading as "Sultan Healthcare" |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 00699-0404-01 (00699040401)
| NDC Package Code | 0699-0404-01 |
|---|---|
| Billing NDC | 00699040401 |
| Package | 28 g in 1 JAR (0699-0404-01) |
| Marketing Start Date | 1963-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3ac8133e-e5ac-42f1-9ce6-80eee07b83bb Details
SPL UNCLASSIFIED SECTION
1. DESCRIPTION
2. INDICATIONS
3. CONTRAINDICATIONS
4. PRECAUTIONS
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.
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
INGREDIENTS AND APPEARANCE
| DRY SOCKET
guaiacol and eugenol paste |
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| Labeler - Dentsply LLC, Professional Division, trading as "Sultan Healthcare" (167087753) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Dentsply Caulk | 083235549 | MANUFACTURE(0699-0404) | |
Revised: 1/2022
Document Id: 4e832f3c-e9b8-4016-97d8-29660f8720e8
Set id: 3ac8133e-e5ac-42f1-9ce6-80eee07b83bb
Version: 3
Effective Time: 20220118