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AquaWhite Blue Gel Cavity FightingTooth

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

Medically reviewed on Jan 16, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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