Opalescence Whitening Toothpaste description, usages, side effects, indications, overdosage, supplying and lots more!

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Opalescence Whitening Toothpaste

Ultradent Products, Inc.

Opalescence whitening toothpaste


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Sodium Fluoride 0.25%w/w

Purpose

Anticavity

Use

aids in the prevention of dental decay.

Warning

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 thoroughly, 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 Ingredients

Glycerin, Water (aqua), Silica, Sorbitol, Xylitol, Flavor (aroma), Poloxamer, Sodium Lauryl Sulfate, Carbomer, FD&C Blue#1 (CI 42090), FD&C Yellow#5 (CI 19140), Sodium Benzoate, Sodium Hydroxide, Sparkle (CI 77019, CI 77891), Sucralose, Xanthan Gum

Manufactured by Ultradent Products, Inc.
www.ultradent.com 800.552.5512
South Jordan, Utah 84095, USA
30302.11 030910

PRINCIPAL DISPLAY PANEL - 133g Box

Opalescence ®
whitening toothpaste

Cool Mint with Fluoride

NET WT. 4.7 oz 133g

Opalescence Whitening Toothpaste

Opalescence Whitening Toothpaste

Sodium Fluoride GEL, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51206-302
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.070875 g

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
SODIUM BENZOATE
Xylitol
SILICON DIOXIDE
methyl salicylate
GLYCERIN
saccharin sodium
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
XANTHAN GUM
SODIUM LAURYL SULFATE

Product Characteristics

Color
GREEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28.35 in 1 TUBE
2 133 in 1 TUBE
3 NDC:51206-302-06 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 1994-07-01


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