Tanners Tasty Ooh La La Orange Paste, Dentifrice
FDA Label NDC 11527-045
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sheffield Pharmaceuticals Llc for the product Tanners Tasty Ooh La La Orange (NDC 11527-045). 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 drug facts:, active ingredient:, uses:, warnings:, directions:, inactive ingredients:, principal panel 4.2 oz tube, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient:
Sodium fluoride - 0.243%
Uses:
- Aids in the prevention of dental decay
Warnings:
- If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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 doctor.
- Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing), and and only use a pea size amount.
- Supervise children as necessary until capable of using without supervision.
- Chlidren under 2 years of age: Conmsult a dentist or doctor.
Inactive Ingredients:
Inactive Ingredients: Sorbitol, Purified Water, Hydrated Silica, Xylitol, Glycerin, Cocamidopropyl Betaine, Flavor, Cellulose Gum, Titanium Dioxide, Disodium Phosphate, Sucralose
Principal Panel 4.2 Oz Tube
Tanner Tasty Paste NDC 11527-045-42
0.243% Sodium Fluoride Toothpaste
Ooh La La Orange
NET WT. 4.2 oz (119g)
Principal Panel 4.2 Oz Tube (256971 Tanners Oohlalaorange 4.2oz)
* Please review the disclaimer below.
