Anticavity Mouth Rinse

Anticavity Mouth Rinse

Drug Labeling and Warnings

Drug Details

k">

ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash 
Harris Teeter

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.

----------

Anticavity Mouth Rinse

Active ingredient

Sodium fluoride 0.0221% (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 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 20⁰ -25⁰ C (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product

Inactive ingredients

water, alcohol (21.6%), sorbitol, poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphori acid, sucralose, menthol, disosium phosphate, red 40, blue 1

This product is not manufacturd or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash*

Proudly Distributed By:
Harris Teeter
Matthew, NC 28105
your plus guaranteed
1-800-432-6111 or harristeeter.com

Principal Display Panel

Compare to the active ingredient in Listerine Total Care

Harris Teeter

ANTICAVITY MOUTH RINSE

Sodium Fluoride and Acidulated Phosphate Topical Solution

EUCALYPTUS MINT

Helps prevent cavities

Restores enamel

Helps strengthen teeth

Helps kill germs that cause bad breath

IMPORTANT: Read directions for proper use.

Sealed With Printed Neckband For Your Protection

1 L (33.8 FL OZ)

image description

163.004/163AE

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72036-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
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 (UNII: L7T10EIP3A)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72036-001-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/01/2011
Labeler - Harris Teeter (047279351)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon790752542manufacture(72036-001)

Revised: 12/2018
 
Harris Teeter


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.