OPAL BY OPALESCENCE ORIGINAL- sodium fluoride gel, dentifrice

Opal by Opalescence Original by

Drug Labeling and Warnings

Opal by Opalescence Original by is a Otc medication manufactured, distributed, or labeled by Ultradent Products, Inc., OraTech, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Sodium Fluoride 0.25% w/w

Purpose

Anticavity

Uses

Aids in the prevention of dental decay.

Warnings

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.

Other Information

• Do not use if tamper-evident seal is broken
• Store at room temperature
• Contains FD&C Yellow No. 5 (tartrazine) as a color additive

Inactive Ingredients

Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Methyl Salicylate (flavor), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Cool Mint Flavor, FD&C Blue #1 (CI 42090), FD&C Yellow #5 (CI 19140), Wintermint Flavor, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xantham Gum

Questions or comments

Call toll-free 1.800.496.8330

PRINCIPAL DISPLAY PANEL - 4.7 OZ Tube Carton

opal™
by Opalescence ®

Whitening
Toothpaste

ORIGINAL
COOL MINT

FLUORIDE TOOTHPASTE
NET WT. 4.7 OZ

INGREDIENTS AND APPEARANCE

OPAL BY OPALESCENCE ORIGINAL 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51206-312
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51206-312-02	3 in 1 PACKAGE, COMBINATION	11/19/2023
1	NDC: 51206-312-01	1 in 1 CARTON
1		133 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 Drug	M021	11/19/2023

Labeler - Ultradent Products, Inc. (013369913)

Establishment
Name	Address	ID/FEI	Business Operations
Ultradent Products, Inc.		013369913	manufacture(51206-312) , analysis(51206-312) , label(51206-312) , pack(51206-312)