ANTICAVITY- sodium fluoride mouthwash 
American Sales Company

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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Anticavity Mouthrinse 163

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 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

Inactive ingredients

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

Other information

  • store at controlled room temperature 20⁰ -25⁰ (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product

Sealed With Printed Neckband For Your Protection

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care anticavity Mouthwash.

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

2013 S&S BRANDS, LLC

Quality guaranteed or your money back

principal display panel

Compare to the Active Ingredient of Listerine Total Care Fresh Mint Anticavity Mouthwash*

CARE ONE

ANTICAVITY MOUTH WASH

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

MINT FLAVOR

  • Helps prevent cavities
  • Restores enamel
  • Helps strengthen teeth
  • Helps kill germs that cause Bad breath
  • Freshen Breath

IMPORTANT: Read directions for proper use

33.8 FL OZ (1 L)

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-163
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)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-163-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/12/200509/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/12/200509/19/2023
Labeler - American Sales Company (809183973)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon790752542manufacture(41520-163)

Revised: 9/2023
 
American Sales Company