Antispetic

Manufacturer
Vi-Jon, LLC
Effective date
2022-02-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:52:15

Label at a glance#

ProductAntispetic
Active ingredientEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Label structure13 sections

Dosage and administration

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) 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

Storage and handling

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F)

Label contents#

Full prescribing information#

active ingredients

OTC - ACTIVE INGREDIENT SECTION

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

OTC - PURPOSE SECTION

Antigingivitis, antiplaque

Use

INDICATIONS & USAGE SECTION

help control plaque that leads to gingivitis

Warnings

WARNINGS SECTION

for this product

Do not use

OTC - DO NOT USE SECTION

if you have painful or swollen gums, pus from the 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.

Stop use and ask a dentist if

OTC - STOP USE SECTION

gingivitis, bleeding, or redness persists for more than 2 weeks.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) 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

STORAGE AND HANDLING SECTION

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor

Questions

OTC - QUESTIONS SECTION

Call 1-866-694-3769

SPL UNCLASSIFIED SECTION

Dist. by: Vi-Jon, LLC

8515 Page Ave, St. Louis, MO 63114

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

germ-X

SINCE 1997

DYE FREE ICE MINT

ANTISEPTIC MOUTH RINSE

ANTIGINGIVITIS/ANTIPLAQUE

Kills 99.9% of germs commonly associated with gingivitis

Helps fight germs that cause bad breath

Sealed With Printed Neckband For Your Protection

500 mL (16.9 FL OZ)

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11344-56711344-567-77

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
d630d822-917c-4296-b3ff-30547a34241b4dfd77f1-9749-4e39-9525-2816162b5f6a2023-07-27WarningsExact identifier
spl set id: 4dfd77f1-9749-4e39-9525-2816162b5f6a

Reported adverse events (FAERS/openFDA)#

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