The following Structured Product Label (SPL) was submitted to the FDA by Moon Oral Care, Llc for the product Moon Whitening Gel Anticavity (NDC 82214-004). 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 dosage & administration, warnings, otc - active ingredient, otc - keep out of reach of children, otc - purpose, inactive ingredient, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Directions:
Adults and children 2 years and older:
Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
Do not swallow. To minimize swallowing use a pea-sized amount in children under 6.
Supervise children's brushing until good habits are established.
Children under 2 years ask a dentist.
Contains sodium fluoride. Children of 6 years and younger: Use a pea-sized amount with supervised brushin to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.
Active Ingredient: Sodium Fluoride 0.24% (0.14% w/v active fluoride ion) Anticavity
Keep out of reach of children under 6 years of age. If more than used for brushin is accidentally swallowed, get medical help or contact a Poison Control Center right away. Children of 6 years and younger: Use a pea-sized amount with supervised brushin to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.
Use: Aids in the prevention of dental cavities.
Hydrated Silica, Glycerin, Water, Sorbitol, Sodium Cocoyl Glutamate, Sodium Coco-Sulfate, Sodium Benzoate, MenthaArvensis Leaf Oil, Xanthan Gum, Mentha Piperita (Peppermint Oil), Alcohol, Mica, Carrageenan, Sodium Gluconate, Sodium Hexametaphosphate, Citric Acid, Cocos Nucifera (Coconut) Oil, Disodium Pyophosphate, Stevia Rebaudiana Leaf/Stem Extract, Sucralose, Titanium Dioxide, Carvone, Vanillin, Sodium Sulfate, Gaultheria Procumbens (Wintergreen) Leaf Oil, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Propanediol, Magnesium Chloride, Sea Salt, Camellia Sinensis Extract, Myrciaria Dubia Fruit Extract, Echinacea Angustifolia Leaf Extract, Panax Ginseng Root Extract
Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing.
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