FDA.reportPublic FDA data

Listerine Gum Therapy Antiseptic

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-03-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:34:31

Label at a glance#

ProductListerine Gum Therapy Antiseptic
Active ingredientEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, THYMOL
Label structure10 sections

Dosage and administration

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

Storage and handling

store at room temperature cold weather may cloud this product. Its antiseptic properties are not affected.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Eucalyptol (0.092%)Antiplaque/antigingivitis
Menthol (0.042%)Antiplaque/antigingivitis
Methyl Salicylate (0.060%)Antiplaque/antigingivitis
Thymol (0.064%)Antiplaque/antigingivitis

Use

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 20mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night
  • do not swallow

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature
  • cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol (21.6% v/v), Sorbitol, Poloxamer 407, Benzoic Acid, Zinc Chloride, Sodium Benzoate, Sucralose, Flavor, Sodium Saccharin, Blue 1

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTISEPTIC
LISTERINE
GUM THERAPY
4X
HEALTHIER*

HELPS REVERSE SIGNS OF
EARLY GUM DISEASE: REDNESS,
BLEEDING AND INFLAMMATION

GLACIER MINT
1.0 L (1 Qt 1.8 Fl Oz)

Principal Display Panel - 1.0 L Bottle Label
Principal Display Panel - 1.0 L Bottle Label

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
69968-060469968-0604-5, 69968-0604-1, 69968-0604-9

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
BENZOIC ACID8SKN0B0MIMIACT
ZINC CHLORIDE86Q357L16BIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
EUCALYPTOLRV6J6604TKACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB

Source Document#

Source XML

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
f6c34874-530f-f19e-e053-6394a90af2add9b146a4-1e3d-4aa8-856c-ab393b9570a42023-03-13WarningsExact identifier
spl id: f6c34874-530f-f19e-e053-6394a90af2ad
spl set id: d9b146a4-1e3d-4aa8-856c-ab393b9570a4

Reported adverse events (FAERS/openFDA)#

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