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AquaWhite Blue Gel Cavity FightingTooth

Medically reviewed on January 16, 2018

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.1g in 100g
Labeler: JHS SVENDGAARD LABORATORIES LIMITED
NDC Code: 72025-002

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.

Active Ingredient

Sodium Monofluorophosphate 0.76%

Purpose:

Anticavity

Uses:

Helps protect  against cavities

Warnings:

If you accidentally swallow more than used for brushing, seek professional help 

Keep out of reach of children under 6 years of age

Directions:

  • Adults and children 2 years and older:
  • Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
  • Do not swallow
  • Children under 6 Years of Age
  • To minimize swallowing use a pea-sized amount and supervise children's brushing untill good habits are established.

Children under 2 years of age:

  • Ask a dentist or physician

Inactive Ingredients:

Sorbitor, Water, Silica, Glycerin, Sodium Lauryl Suphate, Flavor, PEG-1500, Sodium Carboxymethylcellulose, Xylitol, Xanthan Gum, Sodium Methyl Paraben, Sodium Phosphate, Sodium Propyl Paraben, Sodium Saccharin, Cooling Crystal, FD&C Blue 1

AQUAWHITE BLUE GEL CAVITY FIGHTINGTOOTH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72025-002
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE 
FD&C BLUE NO. 1 
WATER 
SORBITOL 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
GLYCERIN 
XANTHAN GUM 
MENTHOL 
SACCHARIN SODIUM 
XYLITOL 
Packaging
#Item CodePackage Description
1NDC:72025-002-0180 g in 1 TUBE
2NDC:72025-002-02150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/16/2018
Labeler - JHS SVENDGAARD LABORATORIES LIMITED (675939900)
Establishment
NameAddressID/FEIOperations
JHS SVENDGAARD LABORATORIES LIMITED675939900manufacture(72025-002)

 
JHS SVENDGAARD LABORATORIES LIMITED

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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