Label: DELTA ONE 2019 TUMI COLLINS AMENITY WITH CREST COMPLETE WHITENING SCOPE- sodium fluoride kit
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Contains inactivated NDC Code(s)
NDC Code(s): 37000-020-01, 69491-220-00 - Packager: Buzz Export Services Pty Ltd
- 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 December 27, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Use
- Warnings
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Directions
- adults and children 2 yrs. & older: brush teeth thoroughly after meals of at least twice a day or use as directed by a dentist
- do not swallow
- to minimize swallowing use a pea-sized amount in children under 6
- supervise children's brushing until good habits are established
- children under 2 yrs.: ask a dentist
- Inactive ingredients
- Questions ?
- DELTA ONE 2019 - TUMI COLLINS AMENITY KIT With Crest Complete Whitening + Scope (69491-220-00)
- CREST COMPLETE MULTI-BENEFIT WHITENING PLUS SCOPE 24g (37000-020-01)
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INGREDIENTS AND APPEARANCE
DELTA ONE 2019 TUMI COLLINS AMENITY WITH CREST COMPLETE WHITENING SCOPE
sodium fluoride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69491-220 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69491-220-00 1 in 1 KIT 07/01/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 24 g Part 1 of 1 CREST COMPLETE MULTI-BENEFIT WHITENING PLUS SCOPE
sodium fluoride paste, dentifriceProduct Information Item Code (Source) NDC:37000-020 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALCOHOL (UNII: 3K9958V90M) XANTHAN GUM (UNII: TTV12P4NEE) SACCHARIN SODIUM (UNII: SB8ZUX40TY) GLYCERIN (UNII: PDC6A3C0OX) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM BENZOATE (UNII: OJ245FE5EU) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) BENZOIC ACID (UNII: 8SKN0B0MIM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color green Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-020-01 24 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 07/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/01/2019 Labeler - Buzz Export Services Pty Ltd (747317902)
