HANDY SOLUTIONS CREST CAVITY PROTECTION FLUORIDE ANTICAVITY- sodium fluoride paste, dentifrice 
Navajo Manufacturing Company Inc

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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Crest Cavity Protection Flouride Anticavity Toothpaste

Handy Solutions Crest Cavity Protection FLUORIDE ANTICAVITY TOOTHPASTE


Active ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anti-Cavity 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. and 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 years : ask a dentist

Inactive ingredients

Sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, flavor, sodium phosphate, cellulose gum, carbomer, sodium saccharin, titanium dioxide, blue 1

Questions or comments?

call toll-free 1-800-492-7378

Handy Solutions Crest Cavity Protection

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HANDY SOLUTIONS CREST CAVITY PROTECTION FLUORIDE ANTICAVITY 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-052(NDC:37000-005)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67751-052-011 in 1 TUBE08/21/2013
124 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:67751-052-021 in 1 PACKAGE08/21/2013
224 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/24/201306/24/2014
Labeler - Navajo Manufacturing Company Inc (091917799)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc136941411relabel(67751-052) , repack(67751-052)

Revised: 1/2023
Document Id: e548ce3a-a8e5-094f-e053-2995a90a0837
Set id: 1f7e738f-a9d5-46bb-9a62-d01fa31756fd
Version: 6
Effective Time: 20230101
 
Navajo Manufacturing Company Inc