TARTAR CONTROL PLUS- 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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Mountain Falls_Swan 434.000 434AC

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 6 years to under 12 years of age - supervise use

children under 6 years of age - do not use

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°-86°F)

Inactive ingredients

water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, flavor, sodium saccharin, blue 1

Disclaimer

This product is not manufactured or distribted by Johnson & Johnson Healthcare Products, distributor of Listerine Ultraclean With Everfresh Technology - Artic Mint.

Adverse Reactions

Distributed by:

Vi-Jon, LLC

One Swan Drive

Smyrna, TN 37167

DSP-TN-15000

DSP-M-34

SDS-TN-15012

principal display panel

mountain

falls

Compare

to Listerine

controls

tartar

long

lasting

clean

feel

kills gerns

plaque &

gingivitis

fights

bad

breath

tartar control plus

antiseptic

mouth rinse

antigingivitis/antiplaque mouth rinse

iceberg blue

1.5 L (50.7 FL OZ)

image description

principal display panel

Sealed With Printed Neckband For Your Protection

Swan

TARTAR CONTROL

PLUS

Antiseptic Mouth Rinse

Antigingivitis/Antiplaque

icebeg blue

Kills germs that cause Bad Breath, Plaque + the gum disease Gingivitis

Compare to Listerine Ultraclean With Everfresh Technology - Artic Mint

1 Litter (33.8 FL OZ)

image description

TARTAR CONTROL PLUS
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0869-0434
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)
ZINC CHLORIDE (UNII: 86Q357L16B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0869-0434-12	1499 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2013
2	NDC:0869-0434-13	1251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2013
3	NDC:0869-0434-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2013
4	NDC:0869-0434-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2013
5	NDC:0869-0434-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	06/10/2013

Labeler - Vi-Jon, LLC (790752542)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(0869-0434)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(0869-0434)

Revised: 6/2022

Document Id: 8d028d53-0c0b-46ca-bffb-41582c880432

Set id: 8366066a-1653-4af4-96c4-e0cea9c3f289

Version: 16

Effective Time: 20220607

Vi-Jon, LLC