Aru Gum Health Paste, Dentifrice
FDA Label NDC 70108-288
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ashtel Studios, Inc. for the product Aru Gum Health (NDC 70108-288). 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, purpose, uses, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Stannous Fluoride 0.454%
(0.15% w/v fluoride ion)
Purpose
Anticavity, Antigingivitis
Uses
- Aids in the prevention of cavities
- Helps prevent gingivitis
- Helps control plaque bacteria that contributes to the development of gingivitis.
- Helps interfere with the harmful effects of plaque associated with gingivitis
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.
Directions
- Adults and children 3 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
- Do not swallow.
- Children under 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
- Children under 2 years of age: Consult a dentist or doctor.
Other Information
- Products containing stannous fluoride may produce surface staining of the teeth
- Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
Inactive Ingredients
Sorbitol, Silica, Aqua (Water), Cocamidopropyl Betaine, Flavor, Cellulose Gum, Potassium Sorbate, Stevia Rebaudiana Leaf Extract.
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Packaging
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