Label: LUSTER POWER WHITE DEEP STAIN ERASER- sodium monofluorophosphate gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 57353-106-13, 57353-106-53 - Packager: DENTOVATIONS INC
- 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 26, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children under 12 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away. Avoid contact of the product with the eyes. If irritation (such as redness, swelling or soreness) of the gums or the mouth occurs, discontinue use and consult a dentist.
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LUSTER POWER WHITE DEEP STAIN ERASER
sodium monofluorophosphate gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57353-106 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.88 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) CALCIUM PYROPHOSPHATE (UNII: X69NU20D19) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) WATER (UNII: 059QF0KO0R) HYDROGEN PEROXIDE (UNII: BBX060AN9V) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) CARBOMER 934 (UNII: Z135WT9208) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PIROCTONE OLAMINE (UNII: A4V5C6R9FB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57353-106-53 1 in 1 BOX 12/01/2012 1 NDC:57353-106-13 113 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 final part355 12/01/2012 Labeler - DENTOVATIONS INC (128248676) Registrant - Lornamead Inc. (078584069) Establishment Name Address ID/FEI Business Operations Lornamead Inc. 078584069 manufacture(57353-106)
