AQUAWHITE 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:

Caldium Carbonate, Sorbitor, Water, Silica, Sodium Lauryl Suphate, Titanium Dioxide, Flavor, Sodium Carboxymethylcellulose, Sodium Silicate, Xanthan Gum, Sodium Saccharin, Formaldehyde

image description

AQUAWHITE CAVITY FIGHTINGTOOTH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72025-001
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
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM SILICATE (UNII: IJF18F77L3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72025-001-0118 g in 1 TUBE; Type 0: Not a Combination Product11/29/2016
2NDC:72025-001-0235 g in 1 TUBE; Type 0: Not a Combination Product11/29/2016
3NDC:72025-001-03100 g in 1 TUBE; Type 0: Not a Combination Product11/29/2016
4NDC:72025-001-04200 g in 1 TUBE; Type 0: Not a Combination Product11/29/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/28/2016
Labeler - JHS SVENDGAARD LABORATORIES LIMITED (675939900)
Establishment
NameAddressID/FEIBusiness Operations
JHS SVENDGAARD LABORATORIES LIMITED675939900manufacture(72025-001)

Revised: 1/2018
Document Id: 635f77cf-00a3-5b21-e053-2991aa0a010d
Set id: c98e5f19-8c70-460c-8c75-5fa6001907d5
Version: 1
Effective Time: 20180122
 
JHS SVENDGAARD LABORATORIES LIMITED