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NDC 81740-0001-01 Auraglow Whitening 2.43 mg/g Details
Auraglow Whitening 2.43 mg/g
Auraglow Whitening is a DENTAL PASTE, DENTIFRICE in the HUMAN OTC DRUG category. It is labeled and distributed by Auraglow LLC. The primary component is SODIUM FLUORIDE.
MedlinePlus Drug Summary
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 81740-0001-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluoride
Product Information
| NDC | 81740-0001 |
|---|---|
| Product ID | 81740-001_f1853564-157f-4646-8803-8d53ec932e17 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Auraglow Whitening |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | SODIUM FLUORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PASTE, DENTIFRICE |
| Route | DENTAL |
| Active Ingredient Strength | 2.43 |
| Active Ingredient Units | mg/g |
| Substance Name | SODIUM FLUORIDE |
| Labeler Name | Auraglow LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 81740-0001-01 (81740000101)
| NDC Package Code | 81740-001-01 |
|---|---|
| Billing NDC | 81740000101 |
| Package | 1 TUBE in 1 CARTON (81740-001-01) / 113 g in 1 TUBE |
| Marketing Start Date | 2021-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6b697a7e-bd57-4b02-8897-326c085b2bd8 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
Package Labeling
INGREDIENTS AND APPEARANCE
| AURAGLOW WHITENING
sodium fluoride paste, dentifrice |
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| Labeler - Auraglow LLC (066094893) |
| Registrant - Auraglow LLC (066094893) |