FRESHENUP FLUORIDE COOL MINT- sodium monofluorophosphate paste, dentifrice 
U. S. Nonwovens Corp

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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Freshenup Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (Total Fluoride Content - 1000 ppm approx)

Purpose

Anticavity

Use

regular brushing with fluoride toothpaste helps protect teeth against cavities

Warnings

Keep out of the reach of children

Keep out of the reach of children under 6 years of age. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions

adults and children 2 years and olderbrush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician
children under 6 yearsto minimize swallowing use a pea sized amount and supervise brushing until good habits are established
children under 2 yearsask a dentist or physician

Inactive ingredients

Calcium Carbonate, Sorbitol, Aqua, Silica, Sodium Lauryl Sulphate, Flavour, Sodium Silicate, Tetra Sodium Pyrophosphate, Cellulose Gum, Xanthan Gum, Benzyl Alcohol, Sodium Saccharin, Sodium Benzoate

freshenup​ is a licensed trademark of healthy+KIND Co. Made In India. All rights reserved

PRINCIPAL DISPLAY PANEL

NDC 52553-052-02

ANTICAVITY

Freshenup

FLUORIDE TOOTHPASTE

COOL MINT

SENSITIVE + GENTLE

ENAMEL STRENGTH

Fresh Breath

Strengthen Against Acids

Gentle Whitening

NET WT 3.5 OZ (99.2 g)

Label

FRESHENUP FLUORIDE COOL MINT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52553-052
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)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM SILICATE (UNII: IJF18F77L3)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52553-052-021 in 1 CARTON08/14/2019
199.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/14/2019
Labeler - U. S. Nonwovens Corp (847061520)
Registrant - U. S. Nonwovens Corp (847061520)
Establishment
NameAddressID/FEIBusiness Operations
Dabur India Limited650599231manufacture(52553-052)

Revised: 8/2019
Document Id: 94a2e3c3-0828-4125-8792-977f8fe67653
Set id: 10b92d93-a0ed-42c3-9b00-861784ccc79e
Version: 1
Effective Time: 20190814
 
U. S. Nonwovens Corp