Fresh Mint Listerine Total Care Anticavity Mouthwash Sodium Fluoride and Acidulated Topical Phosphate Solution

Drug Details [pdf]

LISTERINE TOTAL CARE ANTICAVITY - FRESH MINT- sodium fluoride mouthwash
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Fresh Mint Listerine Total Care
Anticavity Mouthwash
Sodium Fluoride and Acidulated Topical Phosphate Solution

Drug Facts

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

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:
- use twice daily after brushing your teeth with a toothpaste
- vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
- do not swallow the rinse
- do not eat or drink for 30 minutes after rinsing
- supervise children as necessary until capable of using without supervision
Children under 12 years of age: consult a dentist or doctor

Other information

store at controlled room temperature 20°- 25°C (68° - 77°F)
cold weather may temporarily cloud this product

Inactive ingredients

water, sorbitol solution, alcohol (21.6%), poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disodium phosphate, FD&C red no.40, FD&C blue no. 1

Questions?

call 1-888-222-0182, or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label

LISTERINE®
TOTAL CARE
FRESH MINT
ANTICAVITY MOUTHWASH
SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

6
BENEFITS
IN 1

Helps Prevent Cavities
Restores Enamel
Strengthens Teeth
Kills Bad Breath Germs
Cleans the Whole Mouth
Freshens Breath

1.0 L (1 Qt. 1.8 Fl Oz)

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

Principal Display Panel - 1.0 L Bottle Label

LISTERINE TOTAL CARE ANTICAVITY - FRESH MINT
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42002-421
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O)	Fluoride ion	0.1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Alcohol (UNII: 3K9958V90M)
Poloxamer 407 (UNII: TUF2IVW3M2)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Eucalyptol (UNII: RV6J6604TK)
Methyl Salicylate (UNII: LAV5U5022Y)
Thymol (UNII: 3J50XA376E)
Phosphoric Acid (UNII: E4GA8884NN)
Sucralose (UNII: 96K6UQ3ZD4)
Menthol, Unspecified Form (UNII: L7T10EIP3A)
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)
FD&C red no. 40 (UNII: WZB9127XOA)
FD&C blue no. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 42002-421-71	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/30/2009	12/01/2019
2	NDC: 42002-421-72	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/30/2009	12/01/2019
3	NDC: 42002-421-73	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/30/2009	12/01/2019
4	NDC: 42002-421-95	95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/30/2009	12/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	11/30/2009	12/01/2019

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 4/2018

Document Id: 93a5a58e-301e-4226-851a-7cf5b515a94a

Set id: 5e265d8d-134d-4627-9b34-037056d9844f

Version: 4

Effective Time: 20180412

Johnson & Johnson Consumer Inc.