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NDC 00363-0855-86 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 Walgreen Co. The primary component is EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL.

Product Information

NDC	00363-0855
Product ID	0363-0855_ee55c98c-2b8d-4e3a-9786-c53237055a16
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	Walgreen Co
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 00363-0855-86 (00363085586)

Pricing Information	N/A
NDC Package Code	0363-0855-86
Billing NDC	00363085586
Package	1000 mL in 1 BOTTLE, PLASTIC (0363-0855-86)
Marketing Start Date	2014-01-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0780b123-a401-405b-9e50-6be818d71d39 Details

Safety Seal

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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

Questions or comments

1-888-593-0593

Disclaimer

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

Adverse Reactions

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com

2013 Walgreen Co.

MADE IN U.S.A. WITH U.S. AND FOREIGN COMPONENTS

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

principal display panel

Well at

Walgreens

NEW

TARTAR CONTROL PLUS

ANTISEPTIC

Mouth Rinse

Antigingivitis/Antiplaque

Kills germs that cause bad breath, plaque & the gum disease gingivitis

FRESH MINT

Compare to Listerine Ultraclean With Everfresh Technology Cool Mint active ingredients

33.8 FL OZ (1 L)

INGREDIENTS AND APPEARANCE

TARTAR CONTROL PLUS

eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0855
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:0363-0855-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/24/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	01/24/2014

Labeler - Walgreen Co (008965063)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(0363-0855)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(0363-0855)

Revised: 1/2022

Document Id: ee55c98c-2b8d-4e3a-9786-c53237055a16

Set id: 0780b123-a401-405b-9e50-6be818d71d39

Version: 11

Effective Time: 20220125