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NDC 36800-0434-77 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 TopCo Associates, LLC. The primary component is EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL.

Product Information

NDC	36800-0434
Product ID	36800-434_496abdef-140f-4a23-92ba-583f7d36dc25
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	TopCo Associates, LLC
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 36800-0434-77 (36800043477)

Pricing Information	N/A
NDC Package Code	36800-434-77
Billing NDC	36800043477
Package	500 mL in 1 BOTTLE, PLASTIC (36800-434-77)
Marketing Start Date	2013-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5fd311cb-d68d-42b1-9129-bdfbdb96f5a0 Details

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

Disclaimer

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

Adverse Reactions

Distributed by Topco Associates LLC

Elk Grove, Il 60007

1-888-423-0139

[email protected]

DSP-TN-15000

DSP-MO-34

principal display panel

COMPARE TO LISTERINE ULTRACLEAN WITH EVERFRES TECHNOLOGY ARCTIC MINT

TopCare

everyday

Tartar Control Plus

Antiseptic Mouthwash

ANTIGINGIVITIS/ANTIPLAQUE

ICEBERG BLUE

Control tartar that can discolor teeth
Kills germs that cause bad breath, plaque & the gun disease gingivitis
Long-lasting clean feel

16.9 FL OZ (1 PT 0.9 FL OZ) 500 mL

INGREDIENTS AND APPEARANCE

TARTAR CONTROL PLUS

eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-434
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:36800-434-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2013
2	NDC:36800-434-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/01/2013

Labeler - TopCo Associates, LLC (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-434)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(36800-434)

Revised: 6/2022

Document Id: 496abdef-140f-4a23-92ba-583f7d36dc25

Set id: 5fd311cb-d68d-42b1-9129-bdfbdb96f5a0

Version: 13

Effective Time: 20220608