Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e32aa65b-ad9c-4d22-9a6c-0c8aca983e2d
Route
ORAL
Published
Effective Date 2012-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (.092 mL) Menthol (.042 mL) Methyl Salicylate (.060 mL) Thymol (.064 mL)
Inactive Ingredients
Water Alcohol Sorbitol Polyoxyl 40 Hydrogenated Castor Oil Poloxamer 407 Benzoic Acid Zinc Chloride Sucralose Sodium Benzoate Fd&c Yellow No. 6 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-10-18

Description

Active ingredients Eucalyptol 0.092%  Menthol 0.024% Methyl salicylate 0.060%  thymol 0.064%


Medication Information

Warnings and Precautions
Warnings
Indications and Usage
Use helps control plaque that leads to gingivitis

Dosage and Administration
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 under 12 years of age - consult a dentist or doctor

•this rinse is not intended to replace brushing or flossing

Description

Active ingredients Eucalyptol 0.092%  Menthol 0.024% Methyl salicylate 0.060%  thymol 0.064%

Section 42229-5
This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Section 44425-7
Other information cold weather may cloud this product.  Its antiseptic propertied are not affected.  Store at room temperature (59⁰-77⁰F).

Section 50565-1
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.

Section 50566-9
Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks.

Section 50570-1
Do not use if you have painful or swollen guns, 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.

Section 51727-6
Inactive ingredients water, alcohol (21.6%), sorbitol solution, flavoring, PEG-40 hydrogenated castor oil, poloxamer 407, benzoic acid, zinc chloride, sucralose and/or sodium saccharin, sodium benzoate, yellow 6, red 40

Section 51945-4
Exchange

Select

ANTISEPTIC

MOUTH RINSE

TARTAR CONTROL CITRUS

Compare to Citrus Advanced Listerine with Tartar Protection

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

Improves Oral hygiene

Helps control tartar that can discolor teeth

Sealed with printed neckband for your protection

1 L (33.8 FL OZ)
Section 55105-1
Purpose

Antigingivitis, Antiplaque

Section 55106-9
Active ingredients

Eucalyptol 0.092%  Menthol 0.024%

Methyl salicylate 0.060%  thymol 0.064%


Structured Label Content

Indications and Usage (34067-9)
Use helps control plaque that leads to gingivitis

Dosage and Administration (34068-7)
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 under 12 years of age - consult a dentist or doctor

•this rinse is not intended to replace brushing or flossing

Warnings and Precautions (34071-1)
Warnings
Section 42229-5 (42229-5)
This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Section 44425-7 (44425-7)
Other information cold weather may cloud this product.  Its antiseptic propertied are not affected.  Store at room temperature (59⁰-77⁰F).

Section 50565-1 (50565-1)
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.

Section 50566-9 (50566-9)
Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks.

Section 50570-1 (50570-1)
Do not use if you have painful or swollen guns, 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.

Section 51727-6 (51727-6)
Inactive ingredients water, alcohol (21.6%), sorbitol solution, flavoring, PEG-40 hydrogenated castor oil, poloxamer 407, benzoic acid, zinc chloride, sucralose and/or sodium saccharin, sodium benzoate, yellow 6, red 40

Section 51945-4 (51945-4)
Exchange

Select

ANTISEPTIC

MOUTH RINSE

TARTAR CONTROL CITRUS

Compare to Citrus Advanced Listerine with Tartar Protection

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

Improves Oral hygiene

Helps control tartar that can discolor teeth

Sealed with printed neckband for your protection

1 L (33.8 FL OZ)
Section 55105-1 (55105-1)
Purpose

Antigingivitis, Antiplaque

Section 55106-9 (55106-9)
Active ingredients

Eucalyptol 0.092%  Menthol 0.024%

Methyl salicylate 0.060%  thymol 0.064%


Advanced Ingredient Data


Raw Label Data

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