Active Ingredients:
Sodium Fluoride 0.24%
Gel 1100 Gel, Dentifrice
FDA Label NDC 61578-213
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dental Alliance Holdings Llc for the product Gel 1100 (NDC 61578-213). 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 ingredients:, purpose:, use:, warnings:, directions:, inactive ingredients:, gel 1100 mint, citrus, and grape enclosure and carton labels, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Anticavity
Use:
Aids in the prevention of dental caries (cavities)
Warnings:
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Adults and children 6 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 under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.
Inactive Ingredients:
Glycerin, Hydrated Silica, Hydrogenated Starch Hydrolysate (HSH), Hydroxyapatite, Hydroxyethyl Cellulose, Menthol (Mint only), Natural Flavors, Artificial Flavors (Citrus and Grape only) Polysorbate 20, Potassium Sorbate, Saccharin, Sodium Benzoate, Sodium Bicarbonate, Sodium Hydroxide, Sodium Lauryl Sulfate, Water, Xylitol
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