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 - 9181

Active Ingredient
Drug Facts

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste

Use

Aids in the prevention of cavities

Warnings

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

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.

ADVANCED FLUORIDE ANTICAVITY product label

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 Anticavity Toothpaste

Advanced Anticavity Toothpaste

Advanced Anticavity Toothpaste

ADVANCED FLUORIDE ANTICAVITY 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9181
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29500-9181-61 in 1 PACKAGE07/24/2017
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: 8/2017
Document Id: 3113d887-5ed1-4aa3-8725-913db8c3dfba
Set id: 7881ff17-5188-47e6-8d2b-9c296ce35411
Version: 1
Effective Time: 20170801
 
Personal Care Products, LLC