Label: PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH- sodium fluoride mouthwash
-
Contains inactivated NDC Code(s)
NDC Code(s): 62111-0212-4 - 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- WARNINGS
-
Directions
-
Adults and children 12 years of
age or older:
• use twice daily after brushing your
teeth with a toothpaste
• vigorously swish 10 ml (2 teaspoonfuls)
of rinse between your teeth for 1 minute
and then spit out
• do not swallow the rinse
• do not eat or drink for 30 minutes
after rinsing
• supervise children as necessary until
capable of using without supervision
• Children under 12 years of age consult
a dentist or doctor
-
- Inactive ingredients
- Other information
- Questions?
-
PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH with Fluoride (62111-0212-4)
advanced dental
health + beauty
Arthur Glosman DDS
Beverly Hills
PROFESSIONAL
WHITENING SYSTEM
WHITENING
MOUTH WASH
with Fluoride
7.4 fl. oz. / 220 mL
Active ingredient Purpose
SODIUM FLUORIDE 0.02% Anticavity
With Hydrogen Peroxide to help whiten
teeth; a refreshing mint flavor; menthol
for a cooling sensation; and Salvadora
Persica also known as nature’s tooth
brush.
Important:
■Read directions on carton for proper
use.
Directions for use:
■Use twice daily after brushing, with
Dr. Glosman’s WHITENING TOOTHPASTE
■vigorously swish 10 ml, (2 teaspoons)
between the teeth for 1 minute and
then spit out.
■Do not swallow.
Distributed by:
AKG Innovations, LLC
450 N. Roxbury Drive
Suite 222
Beverly Hills, CA 90210
Made in USA
A refreshing, mint flavoredwash, specially formulated with Hydrogen Peroxide for a healthier looking, whiter smile, menthol to cool the mouth and Salvadora Persica, also known as nature’s tooth brush. When used in conjunction with twice daily, regular brushing and flossing, this refreshing wash 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
-
INGREDIENTS AND APPEARANCE
PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62111-0212 Route of Administration oral Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION .2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) CASTOR OIL (UNII: D5340Y2I9G) MENTHOL (UNII: L7T10EIP3A) HYDROGEN PEROXIDE (UNII: BBX060AN9V) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) ASCORBIC ACID (UNII: PQ6CK8PD0R) SALVADORA PERSICA ROOT (UNII: 526M7ZU616) ZINC LACTATE (UNII: 2GXR25858Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62111-0212-4 220 mL in 1 BOTTLE 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(62111-0212)