Oral Dent

Manufacturer: International Cosmetic Limited
Effective date: 2014-03-14
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:38:43

Label at a glance#

ProductOral Dent Citrus

Active ingredientEUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL

Label structure10 sections

Indications and uses

Helps kill germs that cause plaque, gingivitis and bad breath.

Dosage and administration

Rinse Full Strength with 2/3 ounce (20 ml) for 30 seconds twice a day to help kill germs that cause bad breath, plaque and gingivitis.

Contacts and useful links#

PhoneLabel contact1-868-675-2674

Label contents#

Full prescribing information#

Active ingredients (W/V)

OTC - ACTIVE INGREDIENT SECTION

Eucalyptol 0.092%
Thymol 0.064%
Methyl Salicylate 0.060%
Menthol 0.042%

Purpose

OTC - PURPOSE SECTION

Antiplaque/Antigingivitis

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Helps kill germs that cause plaque, gingivitis and bad breath.

Warnings

WARNINGS SECTION

Do not swallow
Not to be used by children under 12 years of age

Directions

DOSAGE & ADMINISTRATION SECTION

Rinse Full Strength with 2/3 ounce (20 ml) for 30 seconds twice a day to help kill germs that cause bad breath, plaque and gingivitis.

Other information

SPL UNCLASSIFIED SECTION

Cold temperature may cloud this product; its efficacy will not be affected. Store at room temperature (59⁰-86⁰F)

Do not use if security band around cap is missing or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol (15%), Sorbitol Solution, Poloxamer 407, Benzoic Acid, Flavour, Sodium Saccharin, Sodium Citrate, Citric Acid, FD&C Yellow No.6, FD&C Red No. 40.

SPL UNCLASSIFIED SECTION

Manufactured for

International Cosmetics Ltd.

ICL Drive, Bhagowtie Trace,

San Juan, Trinidad & Tobago, W.I.

INFO. CALL:1-868-675-2674

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oral dent carton

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1043619	Eucalyptol/Menthol/Methyl salicylate/Thymol (Mouthwash)	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	PSN	2
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	2
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66969-6015-5	2020-01-31	C162847	48780-1	9d75b9d0-cda5-f424-e053-dadaa90a57ce	Oral Dent Citrus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66969-6015-5	Oral DentCitrus	1000 mL in 1 BOTTLE	MOUTHWASH	1000		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66969-6015	ORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETIC LIMITED]	2	Legacy NDC, 1 package rows	20140315_084088c9-e7d6-48ea-bed9-6b4cd54141dc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
EUCALYPTOL	ACTIVE INGREDIENT	RV6J6604TK	2
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	2
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	2
THYMOL	ACTIVE INGREDIENT	3J50XA376E	2
EUCALYPTOL	ACTIVE MOIETY	RV6J6604TK	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	2
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	2
THYMOL	ACTIVE MOIETY	3J50XA376E	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	2
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	2
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Oral Dent Citrus
Eucalyptol, Thymol, Methyl Salicylate, Menthol
EUCALYPTOL
THYMOL
METHYL SALICYLATE
SALICYLIC ACID
MENTHOL
WATER
ALCOHOL
SORBITOL
POLOXAMER 407
BENZOIC ACID
SACCHARIN SODIUM
SODIUM CITRATE
CITRIC ACID MONOHYDRATE
FD&C YELLOW NO. 6
FD&C RED NO. 40

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66969-6015	66969-6015-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
EUCALYPTOL	RV6J6604TK	ACTIB
THYMOL	3J50XA376E	ACTIB
METHYL SALICYLATE	LAV5U5022Y	ACTIB
MENTHOL	L7T10EIP3A	ACTIB
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
SORBITOL	506T60A25R	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
FD&C RED NO. 40	WZB9127XOA	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 · 325 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CONCENTRATE / ORAL	5.3 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	ELIXIR / ORAL		90 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / ORAL		269 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, EXTENDED RELEASE / ORAL	4.59 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	GEL / OPHTHALMIC		1 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / SUBLINGUAL		24 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	FILM / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SOLUTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EXTENDED RELEASE / ORAL		45 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, FILM COATED / ORAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	GEL / PERIODONTAL	155 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL		10 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOAP / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE / ORAL		468 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING / ORAL		83 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE / ORAL		238 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION, CONCENTRATE / INTRAVENOUS	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	ELIXIR / ORAL	5.4 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	ELIXIR / ORAL	100 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		385 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 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
2faeb6db-8f12-448e-b7ad-19b86f506192			084088c9-e7d6-48ea-bed9-6b4cd54141dc	2014-03-14	Warnings	Exact identifier spl id: 2faeb6db-8f12-448e-b7ad-19b86f506192 spl set id: 084088c9-e7d6-48ea-bed9-6b4cd54141dc

Reported adverse events (FAERS/openFDA)#

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

Oral Dent

Label at a glance#

Indications and uses

Dosage and administration

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients (W/V)

Purpose

Keep out of reach of children.

Uses

Warnings

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

Packaging

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#