SKYLINE HERBALS- sodium monofluorophosphate paste, dentifrice 
SKYLINE HERBALS PRIVATE 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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SKYLINE Fluoride Toothpaste

Drug Facts

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Purpose

Anticavity Toothpaste

Use

aids in the prevention of dental cavities

Warning

Warning

Directions

Other Information

Inactive Ingredients

Calcium Carbonate, Water, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Sodium Carboxymethyl Cellulose, Flavor, Sodium Saccharin, Sodium Methyl Paraben, Sodium Propyl Paraben

PRINCIPAL DISPLAY PANEL - 43 g Tube Carton

Drug Fact Panel

SKYLINE HERBALS 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80239-9138
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80239-9138-643 g in 1 TUBE; Type 0: Not a Combination Product07/23/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/23/2019
Labeler - SKYLINE HERBALS PRIVATE LIMITED (877566114)

Revised: 8/2020
Document Id: ae30c235-46b0-65a3-e053-2995a90a7adf
Set id: ae30bf18-8b14-1519-e053-2a95a90a5628
Version: 1
Effective Time: 20200831
 
SKYLINE HERBALS PRIVATE LIMITED