AQUAWHITE BLUE GEL CAVITY FIGHTINGTOOTH- sodium monofluorophosphate paste, dentifrice 
JHS SVENDGAARD LABORATORIES LIMITED

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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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:

Children under 2 years of age:

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

image description

AQUAWHITE BLUE GEL CAVITY FIGHTINGTOOTH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72025-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE (UNII: SE337SVY37)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MENTHOL (UNII: L7T10EIP3A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XYLITOL (UNII: VCQ006KQ1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72025-002-0180 g in 1 TUBE; Type 0: Not a Combination Product01/16/2018
2NDC:72025-002-02150 g in 1 TUBE; Type 0: Not a Combination Product01/16/2018
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/FEIBusiness Operations
JHS SVENDGAARD LABORATORIES LIMITED675939900manufacture(72025-002)

Revised: 1/2018
Document Id: 62e85fcc-0701-17a9-e053-2991aa0ac526
Set id: 8002ddc8-9a7b-407d-8c20-51e5736fd65a
Version: 1
Effective Time: 20180116
 
JHS SVENDGAARD LABORATORIES LIMITED