Label: PROFESSIONAL WHITENING SYSTEM WHITENING- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 62111-0213-2 - Packager: AKG Innovations 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 February 14, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- WARNINGS
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Directions
Supervise children as necessary until capable of using without supervision.
■ Adults and children 6 years of age and older, brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a
dentist or physician.
■ Children under 12 years, instruct in good brushing and rinsing habits (to minimize swallowing).
■ Children under 6 years, do not use unless directed by a dentist or physician.
- Inactive Ingredients
- Questions or comments:
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PROFESSIONALWHITENING SYSTEM WHITENINGTOOTHPASTE with Fluoride 113.6 g (62111-0213-2)
advanced dental
health +beauty
ARTHUR GLOSMAN DDS
Beverly Hills
PROFESSIONAL
WHITENING SYSTEM
WHITENING
TOOTHPASTE
with Fluoride
Net Wt. 4.2 oz. / 113.6 g
A refreshing, peppermint flavored toothpaste, formulated with Hydrogen Peroxide for a healthier looking, whiter smile, silica tohelp remove surface stains, menthol to cool and Salvadora Persica, also known as nature’s tooth brush. When used in conjunctionwith twice daily flossing and rinsing with Whitening Mouth Wash this invigorating toothpaste helps promote good oral hygiene.
The Dr. Glosman Dental Beauty line contains dental products as well as skin treatments:
Professional Whitening System with Refills
Professional Whitening Pen
Whitening Toothpaste with Fluoride
Whitening Mouth Wash with Fluoride
Slim Sonic Tooth Brush
Moisturizing Lip Balm
Lip Enhancer Gloss
Lip Area Rescue Treatment
Important:
Read directions on
carton for proper use.
Distributed by:
AKG Innovations, LLC
450 N. Roxbury Drive
Suite 222
Beverly Hills, CA 90210
Made in USA #90215
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INGREDIENTS AND APPEARANCE
PROFESSIONAL WHITENING SYSTEM WHITENING
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62111-0213 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.23 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) XYLITOL (UNII: VCQ006KQ1E) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) SODIUM SARCOSINATE (UNII: 6EHN3PQL8Z) CARRAGEENAN (UNII: 5C69YCD2YJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYDROGEN PEROXIDE (UNII: BBX060AN9V) MENTHOL (UNII: L7T10EIP3A) SALVADORA PERSICA ROOT (UNII: 526M7ZU616) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62111-0213-2 1 in 1 PACKAGE 1 113.6 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/14/2014 Labeler - AKG Innovations LLC (056576137) Establishment Name Address ID/FEI Business Operations Wasatch Product Development LLC 962452533 manufacture(62111-0213)