Ultimate White Sensitive Whitening
FDA Label NDC 70108-075
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 Ultimate White Sensitive Whitening (NDC 70108-075). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Potassium Nitrate (5%)
Sodium Fluoride 0.24% (0.15% w/v fluoride ion)
Purpose
Antihypersensitivity
Anticavity
Uses
• builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact • aids in the prevention of dental cavities
Warnings
Stop use and ask a dentist if • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 12 years of age. If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.
Directions
• Adults and children 12 years & older: • apply at least a 1-inch strip of the product onto a soft bristle toothbrush • brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. • minimize swallowing. Spit out after brushing. • Children under 12 years of age: Consult a dentist or doctor.
Other Information
Store at room temperature 68-77°F (20-25°C)
Inactive Ingredients
Sorbitol, Hydrated Silica, Treated Water, PEG-1500, Sodium Lauryl Sulfate, Flavor, Glycerin, Cellulose Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, Sodium Benzoate, Trisodium Phosphate, Sodium Saccharin, Sodium Hydroxide, Methylparaben, Propylparaben
Questions Or Comments?
1-877-274-8358
Packaging
Ashtel-075 (7010807501 1)
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