OPAL BY OPALESCENCE COMPLETE gel, dentifrice

Opal by Opalescence Complete by

Drug Labeling and Warnings

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

Drug Details [pdf]

WARNINGS

Keep out of reach of children under 6 years of age. If more than used for burshing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT

INDICATIONS & USAGE

KEEP OUT OF REACH OF CHILDREN

PURPOSE

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OPAL BY OPALESCENCE COMPLETE 
opal by opalescence complete gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51206-313
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
FLAVOR SPICE MINT N&A110589 (UNII: KG6KU384XW)
ZINC CITRATE (UNII: K72I3DEX9B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
GLYCERIN (UNII: PDC6A3C0OX)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SORBITOL (UNII: 506T60A25R)

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: 51206-313-01	1 in 1 CARTON	10/21/2024
1		133 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51206-313-02	12 in 1 PACKAGE, COMBINATION	10/21/2024
2		1 in 1 CARTON
2		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	10/21/2024

Labeler - Ultradent Products, Inc. (013369913)

Establishment
Name	Address	ID/FEI	Business Operations
Ultradent Products, Inc.		013369913	analysis(51206-313) , manufacture(51206-313) , label(51206-313) , pack(51206-313)