Otc - Purpose
Anticavity
Shopkins Mouth Wash
FDA Label NDC 70108-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ashtel Studios Inc. for the product Shopkins Mouth Wash (NDC 70108-008). 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 - purpose, otc - keep out of reach of children, otc - active ingredient, indications & usage, warnings, inactive ingredient, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental digestion seek professional assistance or contact a poison control center immediately.
Otc - Active Ingredient
Active Ingredient Purpose
Sodium Fluoride 0.5% (0.23% w/v fluoride ion) ......................... Anticavity
Indications & Usage
Helps protect teeth and roots against cavities
Warnings
keep out of reach of children.
If you accidentally swallow seek medical help or contact a poison control center immediately
Inactive Ingredient
Water, Glycerine,PEG-40 Hydrogenated Castor Oil,Propylene Glycol,Xylitol,Benzyl Alcohol, Flavor, Sodium Benzoate, Sodium Saccharin, Zinc Gluconate, FD&C Red 40, D&C Red 33
Dosage & Administration
Adults and children 6 years and older:
Use daily after your normal brushing. Rinse toothpaste from your mouth prior to ouse.
Rinse or gargle for 30 seconds with 15ml (3 teaspoonful) and then spit it out.
Do not swallow the mouth wash
* Please review the disclaimer below.
