DRY SOCKET- guaiacol and eugenol paste

Dry Socket by

Drug Labeling and Warnings

Dry Socket by is a Prescription medication manufactured, distributed, or labeled by Dentsply LLC, Professional Division, trading as "Sultan Healthcare", Dentsply Caulk. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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.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

INGREDIENTS AND APPEARANCE

DRY SOCKET 
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)