PRIYAL- sodium monofluorophosphate paste, dentifrice

Priyal by

Drug Labeling and Warnings

Priyal by is a Otc medication manufactured, distributed, or labeled by Priyal Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

WARNINGS

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

INGREDIENTS AND APPEARANCE

PRIYAL 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72822-900
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72822-900-53	43 g in 1 TUBE; Type 0: Not a Combination Product	05/27/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/27/2013

Labeler - Priyal Cosmetics (675482356)

Establishment
Name	Address	ID/FEI	Business Operations
Priyal Cosmetics		675482356	manufacture(72822-900)