ADVANCED FLUORIDE ANTICAVITY - 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 FLUORIDE ANTICAVITY TOOTHPASTE

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.


CAVITY FIGHTING TOOTHPASTE

Distributed by:

Personal Care Products, LLC

Bingham Farms, MI 48025-2463

Made in China

Advanced Fluoride Anticavity Toothpaste

New Ultra Breath Freshener Stripe

Net Wt 6.4oz (181g)

Multi
Protection

Fights Cavities

Freshens Breath

Advanced Whitening Toothpaste

Advanced Whitening Toothpaste

Advanced Whitening Toothpaste

ADVANCED FLUORIDE ANTICAVITY 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-0819
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29500-0819-61 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 Li'erkang Daily Used Chemicals Co., Ltd.531075083manufacture

Revised: 8/2011
Document Id: aa6d87e0-cfa1-4cc0-af22-0036fca25bfd
Set id: 594d5fbc-a134-45ac-a8a7-d4d49d753ac7
Version: 5
Effective Time: 20110818
 
Personal Care Products, LLC