Label: OPALESCENCE WHITENING- sodium fluoride gel, dentifrice
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NDC Code(s):
51206-302-06,
51206-302-07,
51206-302-08,
51206-302-09, view more51206-302-10, 51206-302-11
- Packager: Ultradent Products, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 22, 2024
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 Ingredients
- Purpose
- Uses
- Warnings
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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
- Inactive Ingredients
- Questions or comments
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 ml Tube Box
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INGREDIENTS AND APPEARANCE
OPALESCENCE WHITENING
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51206-302 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 WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SODIUM BENZOATE (UNII: OJ245FE5EU) XYLITOL (UNII: VCQ006KQ1E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) METHYL SALICYLATE (UNII: LAV5U5022Y) GLYCERIN (UNII: PDC6A3C0OX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM LAURYL SULFATE (UNII: 368GB5141J) 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:51206-302-07 1 in 1 BOX 07/01/1994 1 28.35 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51206-302-10 24 in 1 PACKAGE, COMBINATION 06/01/2016 2 1 in 1 BOX 2 28.35 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:51206-302-06 1 in 1 BOX 07/01/1994 3 133 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:51206-302-08 3 in 1 PACKAGE, COMBINATION 06/01/2016 4 1 in 1 BOX 4 133 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:51206-302-09 12 in 1 PACKAGE, COMBINATION 06/01/2016 5 1 in 1 BOX 5 133 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:51206-302-11 6 in 1 PACKAGE, COMBINATION 08/24/2020 6 1 in 1 BOX 6 133 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 07/01/1994 Labeler - Ultradent Products, Inc (013369913) Establishment Name Address ID/FEI Business Operations Ultradent Products, Inc. 013369913 manufacture(51206-302) , analysis(51206-302) , label(51206-302) , pack(51206-302)