ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash
Vi-Jon, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dye-Free Antiseptic Mint Mouthrinse
567.000/567AA

active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Use

help control plaque that leads to gingivitis

Warnings

for this product

Do not use

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

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

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 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

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

Inactive ingredients

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

Questions

Call 1-866-694-3769

Dist. by: Vi-Jon, LLC

8515 Page Ave, St. Louis, MO 63114

principal panel display

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 description

ANTISPETIC
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11344-567
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.60 mg in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11344-567-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/20/2021	07/27/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	12/20/2021	07/27/2023

Labeler - Vi-Jon, LLC (790752542)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(11344-567)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(11344-567)

Revised: 7/2023

Document Id: d630d822-917c-4296-b3ff-30547a34241b

Set id: 4dfd77f1-9749-4e39-9525-2816162b5f6a

Version: 4

Effective Time: 20230727

Vi-Jon, LLC

Dye-Free Antiseptic Mint Mouthrinse567.000/567AA