ANTICAVITY- sodium fluoride mouthwash 
Foodhold U.S.As., LLC

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Care  One 435

Active Ingredient

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

For this product

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 6 years of age and older:

  • use twice a day 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
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

Inactive ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Other information

store at room temperature (59º-77ºF)

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine HealthyWhite Vibrant Anticavity Mouthrinse

Adverse Reactions

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

S & S brands, LLC

1-887846-8484

Quality Guaranteed or your money back

435.000/435AA

principal display panel

Compare to Listerine Healthy White Vibrant Anticavity Mouthrinse

Sealed With Printed Neckband For Your Protection

IMPORTANT: read directions for proper use.

Care One

GLOWING WHITE

ANTICAVITY

MOUTHRINSE

FRESH MINT FLAVOR

  • Begins Working On Contact
  • 5 days to Whiter Teeth
  • Helps Strengthen Teeth
  • Kills Germs that Cause Bad Breqath

16 FL OZ (473 mL)

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-435
Route of Administrationoral
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MENTHOL (UNII: L7T10EIP3A)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-435-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/201504/21/2021
2NDC:41520-435-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/201504/21/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02106/01/201504/21/2021
Labeler - Foodhold U.S.As., LLC (809183973)
Registrant - Vi-Jon, Inc. (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, Inc.790752542manufacture(41520-435)

Revised: 10/2023
Document Id: 12e67d2f-04ee-4b3e-a801-bcbc26a5572d
Set id: 199cd16b-51ce-4728-bff1-e220fc3a6482
Version: 7
Effective Time: 20231023
 
Foodhold U.S.As., LLC