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NDC 49035-0855-12 Tartar control plus .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL Details

Tartar control plus .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL

Tartar control plus is a ORAL MOUTHWASH in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores, Inc.,. The primary component is EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL.

Product Information

NDC	49035-0855
Product ID	49035-855_8d58ae2e-c3b7-4309-b3ae-07076d7165ae
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Tartar control plus
Proprietary Name Suffix	n/a
Non-Proprietary Name	Eucalyptol, menthol, methyl salicylate, thymol
Product Type	HUMAN OTC DRUG
Dosage Form	MOUTHWASH
Route	ORAL
Active Ingredient Strength	.92; .42; .6; .64
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Labeler Name	Wal-Mart Stores, Inc.,
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0855-12 (49035085512)

Pricing Information	N/A
NDC Package Code	49035-855-12
Billing NDC	49035085512
Package	1500 mL in 1 BOTTLE, PLASTIC (49035-855-12)
Marketing Start Date	2016-09-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4da4ecf6-038e-4a64-83f7-c29d70e83174 Details

Active ingredient

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 yeards 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, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, sodium saccharin, green 3

Questions or comments

1-888-287-1915

Satisfaction guaranteed

Satisfaction guaranteed - For questions or comments please call 1-888-287-1915

Disclaimer

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

DSP-TN-15000 DSP-MO-34 SDS-TN-15012

Adverse Reactions

DISTRIBUTED BY: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

principal display panel

Sealed with Printed Neckband for Your Protection

equate

Compare

to Listerine

Ultraclean Cool Mint

Active

Ingredients

Tartar

Control Plus

Antiseptic Mouthrinse Plus

Antigingivitis/Antiplaque

Long lasting clean feel
Controls Tartar that can discolor teeth
Fresh breath with mouth-cooling sensation

Blue Mint

Made in the

USA

WITH 90% OR MORE US PARTS

Factory Certified

1.5 Liter (50.7 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:49035-855
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 GREEN NO. 3 (UNII: 3P3ONR6O1S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-855-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/10/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	09/10/2016

Labeler - Wal-Mart Stores, Inc., (051957769)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(49035-855)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(49035-855)

Revised: 5/2022

Document Id: 8d58ae2e-c3b7-4309-b3ae-07076d7165ae

Set id: 4da4ecf6-038e-4a64-83f7-c29d70e83174

Version: 14

Effective Time: 20220531