Indications and uses
TO HELP CONTROL PLAQUE THAT LEADS TO GINGIVITIS.
Royal Mouthwash Fresh and Clean Original Mint
- Manufacturer
- Filo America | Ningbo Pulisi Daily Chemical Products Co., Ltd.
- Effective date
- 2013-09-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:36:55
Label at a glance#
ProductRoyal Mouthwash Fresh and Clean Original Mint
Active ingredientEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Label structure7 sections
Dosage and administration
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER. VIGOROUSLY SWISH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) BETWEEN TEETH FOR 30 SECONDS THEN SPI9T 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.
Storage and handling
COLD WATER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED. STORE AT ROOM TEMPERATURE (59°-77°F).
Label contents#
Full prescribing information#
ACTIVE INGREDIENT
EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%
PURPOSE
ANTIPLAQUE/ANTIGINGIVITIS
USES
TO HELP CONTROL PLAQUE THAT LEADS TO GINGIVITIS.
WARNINGS
DO NOT USE IF YOU HAVE PAINFUL OR SWOLLEN GUM LINE, LOOSE TEETH OR INCREASED SPACING BETWEEN THE TEETH. SEE YOUR DENTIST IMMEDIATELY. THESE MAY BE SIGNS OF PERIODONTITIS, A SERIOUS FORM OF GUM DISEASE.
DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE.
STOP USE AND ASK A DENTIST IF GINGIVITIS, BLEEDING OR REDNESS PERSISTS FOR MORE THAN 72 HOURS.
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
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER.
VIGOROUSLY SWISH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) BETWEEN TEETH FOR 30 SECONDS THEN SPI9T 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
COLD WATER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED. STORE AT ROOM TEMPERATURE (59°-77°F).
INACTIVE INGREDIENTS:
WATER (AQUA), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, YELLOW 5, BLUE 1
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1043619 | eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash | PSN | 1 |
| 1043619 | eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash | SCD | 1 |
| 1043619 | eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash | SY | 1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50438-304-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0756-f424-e053-dadaa90a57ce | DRUG FACTS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50438-304-01 | Royal Mouthwash Fresh and Clean Original Mint | 1000 mL in 1 BOTTLE, PLASTIC | LIQUID | 1000 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| EUCALYPTOL | ACTIVE INGREDIENT | RV6J6604TK | 1 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| METHYL SALICYLATE | ACTIVE INGREDIENT | LAV5U5022Y | 1 | |
| THYMOL | ACTIVE INGREDIENT | 3J50XA376E | 1 | |
| EUCALYPTOL | ACTIVE MOIETY | RV6J6604TK | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | 1 | |
| THYMOL | ACTIVE MOIETY | 3J50XA376E | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Royal Mouthwash Fresh and Clean Original Mint
- EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
- EUCALYPTOL
- MENTHOL
- METHYL SALICYLATE
- SALICYLIC ACID
- THYMOL
- WATER
- ALCOHOL
- SORBITOL
- POLOXAMER 407
- BENZOIC ACID
- SACCHARIN SODIUM
- SODIUM BENZOATE
- FD&C YELLOW NO. 5
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50438-304 | 50438-304-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| EUCALYPTOL | RV6J6604TK | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
| METHYL SALICYLATE | LAV5U5022Y | ACTIB |
| THYMOL | 3J50XA376E | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| SORBITOL | 506T60A25R | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, DELAYED RELEASE / ORAL | 0.34 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / DENTAL | 0.05 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | WAFER / ORAL | 8 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, EFFERVESCENT / ORAL | 60 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, FILM COATED / ORAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRALESIONAL | 45 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | LIQUID / ORAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRA-ARTICULAR | 45 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | GEL / TOPICAL | 0.1 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SUPPOSITORY / VAGINAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CONCENTRATE / ORAL | 12.5 mg/5ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAMUSCULAR | 22 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SYRUP / ORAL | 20 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE, DENTIFRICE / DENTAL | 0.5 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SOLUTION / ORAL | 199 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SUSPENSION / RECTAL | 0.1 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / DENTAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET / BUCCAL | 0.11 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | ELIXIR / ORAL | 15 mg/5ml | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, DELAYED RELEASE / ORAL | 3 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CAPSULE / ORAL | 8.5 mg | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | CAPSULE / ORAL | 468 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | OINTMENT / TOPICAL | 0.01 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CAPSULE, EXTENDED RELEASE / ORAL | 0.26 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | INJECTION / INTRAVENOUS | 5 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / RECTAL | 46.18 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CONCENTRATE / BUCCAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | LOZENGE / BUCCAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE, DENTIFRICE / DENTAL | 14 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1dd6b65e-11df-4ec2-93af-70888a53b1b1 | 3830dc3a-98f7-4b56-b3ae-281bb24e2e1f | 2013-09-17 | Warnings | 1dd6b65e-11df-4ec2-93af-70888a53b1b1 3830dc3a-98f7-4b56-b3ae-281bb24e2e1f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.