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

Active Ingredent

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste

Use

Aids in the prevention of cavities

If more than is used for brushing is accidentally swallowed get medical help or contact a poison control center right away.

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

Directions

adults and children 2 years. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.

do not swallow

to minimize swallowing, use a pea-sized amount in children under 6 years old

supervise children's brushing until good habits are established

children under 2y ears: ask a dentist before use.

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.

Distributed by:

Personal Care Products, LLC

Bingham Farms, MI 48025-2463

Made in China

Advanced Whitening Anticavity Fluoride Toothpaste

Net Wt 6.4oz (181g)

Fresh Mint

Fights Tarter Build-up

Advanced Whitening Toothpaste

Advanced Whitening Toothpaste

Advanced Whitening Toothpaste

ADVANCED WHITENING ANTICAVITY FLUORIDE  
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2238
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 100 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:29500-2238-61 in 1 BOX
1181 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/24/2011
Labeler - Personal Care Products, LLC (966155082)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou Lierkang Daily Used Chemicals Co Ltd531075083manufacture

Revised: 12/2011
Document Id: 7bd2de97-4d53-4bc1-9e59-f7e94ae892d9
Set id: aedf174b-a0e8-43d7-9ef4-fa98e1b04b4a
Version: 3
Effective Time: 20111230
 
Personal Care Products, LLC