PRIYAL- sodium monofluorophosphate paste, dentifrice 
Priyal Cosmetics

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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Priyal Toothpaste

Active Ingredient

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

Purpose

Anticavity toothpaste

Uses

aids in the prevention of dental cavities

Warning

Keep out of the reach of children under 6 years of age

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately

Directions

■ do not swallow ■ supervise children as necessary until capable of using without supervision ■ instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) ■ adults and children 6 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor ■ children under 6 years of age: do not use unless directed by a doctor or dentist

Inactive ingredients

calcium carbonate, water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose,Flavor, sodium saccharin, sodium methylparaben, sodium propylparaben

Package Label

Drug Fact Panel

PRIYAL 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72822-900
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 (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72822-900-5343 g in 1 TUBE; Type 0: Not a Combination Product05/27/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/27/2013
Labeler - Priyal Cosmetics (675482356)
Establishment
NameAddressID/FEIBusiness Operations
Priyal Cosmetics675482356manufacture(72822-900)

Revised: 7/2020
Document Id: aa54f625-e021-f159-e053-2a95a90af976
Set id: aa54fa9c-7e2d-8bab-e053-2995a90afaa7
Version: 1
Effective Time: 20200709
 
Priyal Cosmetics