Label: AURAGLOW DAILY- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 81740-002-01 - Packager: Auraglow LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 7, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
• Adults and children 2 years of age and older:
Brush teeth thouroughly, 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 INGREDIENT
- Package Labeling
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INGREDIENTS AND APPEARANCE
AURAGLOW DAILY
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81740-002 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.43 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color white Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81740-002-01 1 in 1 CARTON 08/01/2021 1 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 08/01/2021 Labeler - Auraglow LLC (066094893) Registrant - Auraglow LLC (066094893)