Otc - Active Ingredient
Active Ingredients:
Sodium Fluoride 0.22% (0.126% w/v Fluoride Ion)
Dentek Looney Tunes Kids
FDA Label NDC 60630-498
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dentek Oral Care, Inc. for the product Dentek Looney Tunes Kids (NDC 60630-498). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose:
Anticavity
Indications & Usage
Use:
Helps protect against cavities
Warnings
Warnings:
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
Dosage & Administration
Directions: . Adults and children 2 years of age and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist .Children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) .Children under 2 years: ask a dentist or physician
Inactive Ingredient
Inactive Ingredients: Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Phosphate, Sodium Saccharin, Sodium Hydroxide, CI 45430 (FD&C Red No. 3).
Otc - Questions
Questions? 1-800-433-6835
Toothpaste Tube Label
Looney Toothpaste Tube Label (500498a Looney Paste 091113.1)
* Please review the disclaimer below.
