Label: VORTEX- toothpaste paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 52316-028-42 - Packager: DSC Laboratories, Div. of DSC Products 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 December 6, 2011
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- WARNINGS
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Directions
- Twist off cap and remove foil seal
- Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or use as directed by 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?
- VORTEX TOOTHPASTE 120G TUBE
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INGREDIENTS AND APPEARANCE
VORTEX
toothpaste paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52316-028 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.0 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) XYLITOL (UNII: VCQ006KQ1E) HYDRATED SILICA (UNII: Y6O7T4G8P9) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) XANTHAN GUM (UNII: TTV12P4NEE) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52316-028-42 120 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/30/2011 Labeler - DSC Laboratories, Div. of DSC Products Inc. (097807374) Establishment Name Address ID/FEI Business Operations DSC Laboratories, Div. of DSC Products Inc. 097807374 manufacture