NEWWORLD- sodium monofluorophosphate paste, dentifrice

NEWWORLD by

Drug Labeling and Warnings

NEWWORLD by is a Otc medication manufactured, distributed, or labeled by NEW WORLD HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

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

PURPOSE

Purpose

Anticavity toothpaste

INDICATIONS & USAGE

Use

aids in prevention of dental cavities

WARNINGS

Warnings

KEEP OUT OF REACH OF CHILDREN

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 Centre right away.

DOSAGE & ADMINISTRATION

Directions

• adults and children 2yrs. & older brush teeth thoroughly after meals or at least twice a day or use as instructed by a dentist
• do not swallow
• to minimize swallowing use a pea-sized amount in children under 6 years
• supervise children's brushing until good habits are established
• children under 2 years: ask a dentist

INACTIVE INGREDIENT

Inactive ingredients

calcium carbonate, sorbitol, water, sodium lauryl sulfate, hydrated silica, sodium carboxymethyl cellulose, flavor, sodium silicate, sodium benzoate, sodium saycharin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEWWORLD 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72423-0010
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72423-0010-1	133 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2018
2	NDC: 72423-0010-2	24 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/01/2018

Labeler - NEW WORLD HEALTHCARE PRIVATE LIMITED (873672074)

Establishment
Name	Address	ID/FEI	Business Operations
NEW WORLD HEALTHCARE PRIVATE LIMITED		873672074	manufacture(72423-0010)