Dry Socket

DRY SOCKET- guaiacol and eugenol paste
Dentsply LLC, Professional Division, trading as “Sultan Healthcare”

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.

DIRECTIONS FOR USE

REF 10404 – Dry Socket Paste – 1oz/28g

NPN Number: 02038641

For 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

  1. 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.
  2. Thoroughly rinse and de-bride the socket.
  3. Introduce Dry Socket Paste into the socket using a flat-bladed instrument or a disposable syringe.
  4. Tamp down the Dry Socket Paste, ensuring coverage of all exposed bone.
  5. Do not cover the Dry Socket Paste.
  6. 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.

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.com

Made 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

display panel
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DRY SOCKET
guaiacol and eugenol paste
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0404
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIACOL (GUAIACOL) GUAIACOL 0.0416 g in 1 g
EUGENOL (EUGENOL) EUGENOL 0.0416 g in 1 g
Inactive Ingredients
Ingredient Name Strength
BALSAM PERU
CHLOROBUTANOL
PETROLATUM
YELLOW WAX
XANTHAN GUM
ACACIA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0699-0404-01 28 g in 1 JAR None
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 Operations
Dentsply Caulk 083235549 MANUFACTURE (0699-0404)

Revised: 01/2024 Dentsply LLC, Professional Division, trading as “Sultan Healthcare”

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