Oprecare 24
FDA Label NDC 71764-103

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by O'precare for the product Oprecare 24 (NDC 71764-103). 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 active ingredient, purpose, warnings, uses, directions, keep out of reach of children, inactive ingredients, o'precare 24, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Silica (Silicon dioxide) (2.85%)

Purpose

Anticavity

Warnings

When using this product, if irritation occurs stop use and ask a dentist. Do not swallow, and rinse enough after use. Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center right away.

Uses

Helps protect against cavities, plaque, gingivitis

Directions

Directions 
 Adults and children 2 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 physician
 Children 2 to 6 years Use only a pea sized amount and supervise childs brushing and rinsing (to minimize swallowing)
 Children under 2 years Ask a dentist or physician

Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center right away.

Inactive Ingredients

Silica, Tocopheryl Acetate, Sorbitol, PEG-32, Xylitol, Stevioside, Hydrated Silica, Cellulose Gum, Sodium Methyl Cocoyl Taurate, Menthol, Liquorice, Propolis Extract, Allantoin, Piridokssin Hydrochloride, Camellia Sinensis Leaf Extract, Citron Flavor (fragrance), Lemon Oil, Orange Oil, Eucalyptus Oil, D.I-WATER

* Please review the disclaimer below.