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- Contains inactivated NDC Code(s)
NDC Code(s): 81740-001-01 - 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
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
Drug Facts
- ACTIVE INGREDIENT
Active ingredient
Sodium fluoride 0.243%
See AlsoAuraglow | Frequently Asked QuestionsRisks of Teeth Whitening: What You Need to Know Before Getting Started | Narre Warren Dental Care(0.15% w/v fluoride ion)
- PURPOSE
Purpose Anticavity
-
Use Aids in prevention of dental cavities.
- WARNINGS
Warnings
- KEEP OUT OF REACH OF CHILDREN
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 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
Inactive Ingredients
Sorbitol, hydrated silica, deionized water,
glycerin, hydrogen peroxide, polyethylene
glycol, sodium tripolyphosphate, cellulose
gum, sodium methyl cocoyl tautate,
flavor, stevia, sodium bicarbonate
- Package Labeling
Auraglow
Whitening Toothpaste
Wintergreen
CONTAINS FLUORIDE &
3% HYDROGEN PEROXIDE
NET WT 4.0 OZ (113G)
Distr. by Auraglow LLC, Stamford, CT 06901
res
- INGREDIENTS AND APPEARANCE
AURAGLOW WHITENING
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81740-001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.43mg in1g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A) SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) SODIUM BICARBONATE (UNII: 8MDF5V39QO) 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:81740-001-01 1 in 1 CARTON 07/01/2021 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 07/01/2021 Labeler -Auraglow LLC(066094893)
Registrant -Auraglow LLC (066094893)
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AURAGLOW WHITENING- sodium fluoride paste, dentifrice
Number of versions: 2
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Nov 8, 2022 | 2 (current) | download |
| Jul 1, 2021 | 1 | download |
RxNorm
AURAGLOW WHITENING- sodium fluoride paste, dentifrice
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 891775 | sodium fluoride 0.243 % Toothpaste | PSN |
| 2 | 891775 | sodium fluoride 0.00243 MG/MG Toothpaste | SCD |
| 3 | 891775 | sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste | SY |
| 4 | 891775 | sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste | SY |
| 5 | 891775 | sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste | SY |
| 6 | 891775 | sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste | SY |
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AURAGLOW WHITENING- sodium fluoride paste, dentifrice
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NDC Codes
AURAGLOW WHITENING- sodium fluoride paste, dentifrice
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 81740-001-01 (inactivated) |
