ADVANCED WHITENING ANTICAVITY FLUORIDE- sodium monofluorophosphate paste, dentifrice 
Personal Care Products, LLC

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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ADVANCED WHITENING ANTICAVITY FLUORIDE - 9223

Drug Facts
Active ingredient

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste

Uses

aids in the prevention of cavities

Warnings

If more than used for brushing is accidentally swallowed get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

Keep out of reach of children under 6 yrs of age.

Directions

Inactive ingredients

calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, saccharin sodium, sodium lauryl sulfate, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum.

Advanced Whitening Anticavity product label

Personal Care™

Advanced Whitening Anitcavity Fluoride Toothpaste

FRESH MINT

Fights Tarter Build-up

NET WT 6.4 OZ. (181 G)

Free Soft Toothrush

Distributed by:
Personal Care Products, LLC
Troy, Michigan 48084 U.S.A.
Made in China

PC AdvWhite

ADVANCED WHITENING ANTICAVITY FLUORIDE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9223
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1000 mg  in 181 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29500-9223-61 in 1 BOX07/24/2017
1181 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/24/2017
Labeler - Personal Care Products, LLC (966155082)
Registrant - Personal Care Products, LLC (966155082)

Revised: 7/2017
Document Id: 899b6434-3f80-4f56-bf3d-147230a6d0b3
Set id: 62f9fb4a-d6bf-4050-999b-e198207eae7d
Version: 1
Effective Time: 20170719
 
Personal Care Products, LLC