NATURE MINT ANTICAVITY- sodium monofluorophosphate paste, dentifrice 
Daxal Cosmetics 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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Nature Mint Anticavity

ACTIVE INGREDIENT

Sodium Monofluorophosphate - 0.76% (Total Fluoride Content - 1000 ppm Approx.)

DRUG FACTS

PURPOSE

Anticavity.

USE

Helps protect against cavities.

WARNINGS

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

INACTIVE INGREDIENTS

Calcium Carbonate, Purified Water, Sorbitol, Precipitated Silica, Sodium Lauryl Sulphate, Glycerin, Sodium Carboxy Methyl Cellulose, Flavor, Sodium Saccharin, Sodium Benzoate.

DIRECTIONS:

Adults & Children 6 years of age & older : Brush teeth throughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children 2 to 6 years : Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).

Children under 2 years : Ask a dentist or physician.

PRINCIPAL DISPLAY PANEL - 43 g Tube

display panel

NATURE MINT ANTICAVITY 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76001-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76001-001-017.94 g in 1 PACKET; Type 0: Not a Combination Product01/01/2018
2NDC:76001-001-0217 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
3NDC:76001-001-0324 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
4NDC:76001-001-0443 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
5NDC:76001-001-0578 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
6NDC:76001-001-071 in 1 CARTON01/01/2018
6181 g in 1 TUBE; Type 0: Not a Combination Product
7NDC:76001-001-061 in 1 CARTON01/01/2018
7130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2018
Labeler - Daxal Cosmetics Private Limited (650497790)
Establishment
NameAddressID/FEIBusiness Operations
Daxal Cosmetics Private Limited650497790manufacture(76001-001)

Revised: 8/2019
Document Id: 90044dec-5d5a-13e0-e053-2a95a90ad994
Set id: 90044dec-5d58-13e0-e053-2a95a90ad994
Version: 1
Effective Time: 20190813
 
Daxal Cosmetics Private Limited