ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid 
American Sales Company

----------

Care One 482

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredients

Sodium fluoride 0.02% (0.0 1% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warning

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 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
  • 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, glycerin, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Claims

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurence.

Dislcaimer

Ths product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Complete Anticavity Fluoride Rinse.

482.001/482AB

Adverse reaction

DISTRIBUTED BY:

FODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

principal display panel

Compare to the Active Ingredient in Crest Pro-Health Advanced Anticavity Fluoride Mouthwash

CAREONE

ALCOHOL FREE FLUORIDE

MOUTH

WASH

ANTICAVITY FLUORIDE RINSE

VIOLET MINT FLAVOR

Kils Bad Breath Germs

Helps Prevent Cavities

Helps Strengthen Enamel

Cleans Teeth

Freshens Breath

1 LITER

(3.8 FL OZ)

IMPORTANT: Read directions for proper use

image description

ALCOHOL-FREE ANTICAVITY 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-482
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-482-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/201311/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02102/01/201311/16/2021
Labeler - American Sales Company (809183973)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(41520-482)

Revised: 10/2023
 
American Sales Company