ARC WHITENING- sodium fluoride paste, dentifrice 
Procter & Gamble Manufacturing 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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ARC WHITENING FLUORIDE TOOTHPASTE CHARCOAL

Drug Facts

Active ingredient

Sodium fluoride 0.243% (0.14% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 yrs of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children’s brushing until good habits are established
  • children under 2 yrs.: ask a dentist

Inactive ingredients

glycerin, water, hydrated silica, xylitol, flavor, mentha piperita (peppermint) oil, charcoal powder, sodium cocoyl glutamate, xanthan gum, carrageenan, cocamidopropyl betaine, stevia rebaudiana extract

Questions?

1-866-989-3951

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 113 g tube in carton

ARC

WHITENING

FLUORIDE TOOTHPASTE

CHARCOAL

NET WT 4.0 OZ (113g)

ARC Whitening Toothpaste Charcoal

ARC  WHITENING
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-889
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorblackScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69423-889-401 in 1 CARTON01/05/2021
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/05/2021
Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 4/2022
Document Id: dda4adab-bbd6-d99a-e053-2995a90a227b
Set id: dda499e4-98d2-4407-e053-2995a90ae74b
Version: 1
Effective Time: 20220427
 
Procter & Gamble Manufacturing Company