Mastic Dent

Manufacturer: Chia Gi LTD
Effective date: 2012-12-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:34:02

Label at a glance#

ProductMastic Dent

Active ingredientSODIUM FLUORIDE, EUCALYPTOL, THYMOL, MENTHOL

Label structure10 sections

Dosage and administration

Directions: Adults and children 12 of age and older - Vigorously swish 20mL (2.3 Fl. Oz or 4 tea-spoonfuls) between teeth for 30 seconds then spit out, do not swallow. Children under 12 years of age - Consult a dentist or doctor This rinse is not intended to replace brushing or flossing.

Contacts and useful links#

Websitewww.masticspa.com

www.masticspa.com

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Drug Facts:

Active Ingredients:

Sodium Fluoride 0.025% - Anticavity
Eucalyptol 0.092%, Menthol 0.042% - Antigingivitis , Antiplaque
Thymol 0.064% - Antigingivitis, Antiplaque

Warnings

WARNINGS SECTION

Warning:

Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.
Stop use and ask dentist if gingivitis, bleeding, or redness persists more than 2 weeks.

Keep out of reach.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

INDICATIONS & USAGE SECTION

Directions:

Adults and children 12 of age and older - Vigorously swish 20mL (2.3 Fl. Oz or 4 tea-spoonfuls) between teeth for 30 seconds then spit out, do not swallow.
Children under 12 years of age - Consult a dentist or doctor
This rinse is not intended to replace brushing or flossing.

Other information

OTHER SAFETY INFORMATION

Other Information:

Cold weather may cloud this product. Its anticeptic properties are not affected. Store at room temperature (25 C - 77 F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

AQUA, Alcohol Denaturated, Sorbitol, Sodium Lauroyl Sarcosinate, Sodium Phosphate, Peg-40 Hydrogenated Castor Oil, Sodium Benzoate, Fragrance, Disodium EDTA, Sodium Saccharin, Pistacia Lentiscus Mastic Gum, Pistacia Lentiscus Seed Oil, Acid Blue 9 CI 42090

Information of owner

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Product Of Chios

CHIA GI LTD

144 AG. MINA, HIOS, 82100

GREECE
Tel.: 30-22710-33101, FAX: 30-22710-32229

www.masticspa.com
Made In Greece

PURPOSE SECTION

OTC - PURPOSE SECTION

Reduces Gingivitis

Dosage

DOSAGE & ADMINISTRATION SECTION

Dosage - Vigorously swish 20mL (2/3 Fl. OZ or 4 team - spoonfuls) between teeth for 30 seconds, then spit out do not swallow.

ImageofMouthwash.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ImageofMouthwash.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1363759	eucalyptol 0.092 % / menthol 0.042 % / sodium fluoride 0.025 % / thymol 0.064 % Mouthwash	PSN	2
1363759	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / sodium fluoride 0.25 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	2
1363759	eucalyptol 0.092 % / menthol 0.042 % / sodium fluoride 0.025 % / thymol 0.064 % Mouthwash	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
15304-4085-1	2019-11-27	C162847	48780-1	9855d018-de35-cd31-e053-dbdaa90ab51a	9512b4f1-d933-43d7-b31e-2245e2aa3eee

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
15304-4085-1	Mastic Dent	400 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	400		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15304-4085	MASTIC DENT (SODIUM FLUORIDE, EUCALYPTOL, THYMOL AND MENTHOL) MOUTHWASH [CHIA GI LTD]	2	Legacy NDC, 1 package rows	20121220_9512b4f1-d933-43d7-b31e-2245e2aa3eee.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
EUCALYPTOL	ACTIVE INGREDIENT	RV6J6604TK	2
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	2
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	2
THYMOL	ACTIVE INGREDIENT	3J50XA376E	2
EUCALYPTOL	ACTIVE MOIETY	RV6J6604TK	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	2
THYMOL	ACTIVE MOIETY	3J50XA376E	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
PISTACIA LENTISCUS RESIN	INACTIVE INGREDIENT	7446H202QW	2
PISTACIA LENTISCUS SEED OIL	INACTIVE INGREDIENT	Z7D029774C	2
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SODIUM LAUROYL SARCOSINATE	INACTIVE INGREDIENT	632GS99618	2
SODIUM PHOSPHATE	INACTIVE INGREDIENT	SE337SVY37	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

Mastic Dent
Sodium Fluoride, Eucalyptol, Thymol and Menthol
SODIUM FLUORIDE
FLUORIDE ION
EUCALYPTOL
THYMOL
MENTHOL
SORBITOL
PISTACIA LENTISCUS SEED OIL
PISTACIA LENTISCUS RESIN
SODIUM BENZOATE
ALCOHOL
SACCHARIN SODIUM
SODIUM LAUROYL SARCOSINATE
EDETATE DISODIUM
SODIUM PHOSPHATE
POLYOXYL 40 HYDROGENATED CASTOR OIL
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
15304-4085	15304-4085-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
EUCALYPTOL	RV6J6604TK	ACTIB
THYMOL	3J50XA376E	ACTIB
MENTHOL	L7T10EIP3A	ACTIB
SORBITOL	506T60A25R	IACT
PISTACIA LENTISCUS SEED OIL	Z7D029774C	IACT
PISTACIA LENTISCUS RESIN	7446H202QW	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
ALCOHOL	3K9958V90M	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM LAUROYL SARCOSINATE	632GS99618	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM PHOSPHATE	SE337SVY37	IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 321 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	INJECTION / INTRAMUSCULAR	10.6 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SOLUTION / ORAL	0.04 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RECTAL		97 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / INTRAVENOUS		4050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	TABLET / ORAL	16 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OIL	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	TABLET, EXTENDED RELEASE / ORAL		50 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAMUSCULAR	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / BUCCAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	SUSPENSION / OPHTHALMIC	0.2 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e80dad36-53a2-4d36-96b0-fd12192cd74b			9512b4f1-d933-43d7-b31e-2245e2aa3eee	2012-12-20	Warnings	Exact identifier spl id: e80dad36-53a2-4d36-96b0-fd12192cd74b spl set id: 9512b4f1-d933-43d7-b31e-2245e2aa3eee

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.