FDA.reportPublic FDA data

Listerine Ultraclean Antiseptic

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2018-06-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:54:32

Label at a glance#

ProductListerine Ultraclean Antiseptic Arctic Mint
Active ingredientEucalyptol, Menthol, Unspecified Form, Methyl Salicylate, Thymol
Label structure11 sections

Indications and uses

helps prevent and reduce: plaque gingivitis

Dosage and administration

rinse full strength for 30 seconds with 20 ml (2/3 fluid ounce or 4 teaspoonfuls) morning and night do not swallow

Storage and handling

store at controlled room temperature 20° - 25° C (68° – 77° F) cold weather may cloud this product. Its antiseptic properties are not affected.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purposes

OTC - PURPOSE SECTION

Antiplaque/antigingivitis

Uses

INDICATIONS & USAGE SECTION

helps prevent and reduce:

  • plaque
  • gingivitis

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use in children under 12 years of age

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

DOSAGE & ADMINISTRATION SECTION

  • rinse full strength for 30 seconds with 20 ml (2/3 fluid ounce or 4 teaspoonfuls) morning and night
  • do not swallow

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 20° - 25° C (68° – 77° F)
  • cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol (21.6%), sorbitol solution, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, flavor, sodium saccharin, FD&C blue no. 1

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-888-222-0182 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Dist: Johnson & Johnson Healthcare Products
Division of McNEIL-PPC, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LISTERINE®
ULTRACLEAN®
WITH EVERFRESH™ TECHNOLOGY

ANTISEPTIC

Controls Tartar Build-up,
Kills Plaque & Gingivitis
Germs, Keeps Breath
Fresh for Hours

* vs. brushing alone

ARCTIC MINT®

500 mL (1.05 Pt)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
EucalyptolACTIVE INGREDIENTRV6J6604TK2
MentholACTIVE INGREDIENTL7T10EIP3A2
Methyl SalicylateACTIVE INGREDIENTLAV5U5022Y2
ThymolACTIVE INGREDIENT3J50XA376E2
EucalyptolACTIVE MOIETYRV6J6604TK2
MentholACTIVE MOIETYL7T10EIP3A2
Salicylic AcidACTIVE MOIETYO414PZ4LPZ2
ThymolACTIVE MOIETY3J50XA376E2
AlcoholINACTIVE INGREDIENT3K9958V90M2
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIM2
Fd&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD2
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M22
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TY2
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU2
SorbitolINACTIVE INGREDIENT506T60A25R2
SucraloseINACTIVE INGREDIENT96K6UQ3ZD42
WaterINACTIVE INGREDIENT059QF0KO0R2
Zinc ChlorideINACTIVE INGREDIENT86Q357L16B2

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42002-44842002-448-95, 42002-448-73, 42002-448-72, 42002-448-71, 42002-448-70

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
NameUNIIKind
EucalyptolRV6J6604TKACTIB
Menthol, Unspecified FormL7T10EIP3AACTIB
Methyl SalicylateLAV5U5022YACTIB
Thymol3J50XA376EACTIB
Water059QF0KO0RIACT
Alcohol3K9958V90MIACT
Sorbitol506T60A25RIACT
Poloxamer 407TUF2IVW3M2IACT
Benzoic Acid8SKN0B0MIMIACT
Zinc Chloride86Q357L16BIACT
Sodium BenzoateOJ245FE5EUIACT
Sucralose96K6UQ3ZD4IACT
Saccharin SodiumSB8ZUX40TYIACT
Fd&C Blue No. 1H3R47K3TBDIACT

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 5 · 274 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Fd&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYCAPSULE / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
Fd&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDFILM / SUBLINGUAL0.07 mgExact identifier — unii candidate
37 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMLOTION / TOPICAL0.2 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii candidate
44 equally ranked IID candidates
Fd&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii candidate
37 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMMOUTHWASH / BUCCALNAExact identifier — unii candidate
23 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii candidate
44 equally ranked IID candidates
Fd&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii candidate
35 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii candidate
22 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
Fd&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
Zinc ChlorideZINC CHLORIDE86Q357L16BINJECTION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSPRAY / NASAL49 mgExact identifier — unii candidate
44 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2POWDER, FOR SUSPENSION / ORAL0.01 mgExact identifier — unii candidate
15 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
Fd&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSUPPOSITORY / VAGINAL2 mgExact identifier — unii candidate
23 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2SOLUTION / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
Fd&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii candidate
22 equally ranked IID candidates
Fd&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SPRAY / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii candidate
22 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMTABLET, COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2SUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
15 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION, SOLUTION / INTRAVENOUS4050 mgExact identifier — unii candidate
44 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3967c400-dbcb-49d1-a4d9-3767569b6680d38a273c-3833-4459-9e80-c2b0c779772e2020-09-11WarningsExact identifier
spl set id: d38a273c-3833-4459-9e80-c2b0c779772e

Reported adverse events (FAERS/openFDA)#

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