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

Tartar control plus by

Drug Labeling and Warnings

Tartar control plus by is a Otc medication manufactured, distributed, or labeled by Amazon.com Services LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Use

helps 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

Adverse Reactions

DISTRIBUTED BY:

Amazon. com Services, Inc.

Seattle, WA 98109

1-877-485-0385

2018 Amazon.com Inc. or its affiliates.  All rights reserved.  Solimo and all related  logos are  trademarks of Amazon.com, Inc or its affiliates.

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

434.000/434AB

principal display panel

SOLIMO

Tartar Control Plus

Antiseptic

Mouth Rinse

ANTIGINGIVITS/ANTIPLAQUE

Iceberg bluer mint flavor

1L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-434
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72288-434-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/25/2018

Labeler - Amazon (128990418)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(72288-434)