Other
Drug Facts
Newworld
FDA Label NDC 72423-0010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New World Healthcare Private Limited for the product Newworld (NDC 72423-0010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)
Otc - Purpose
Purpose
Anticavity toothpaste
Indications & Usage
Use
aids in prevention of dental cavities
Warnings
Warnings
Otc - 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
Package Label.Principal Display Panel
* Please review the disclaimer below.
