Label: CHILDRENS OUTRAGEOUS ORANGE MANGO- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 51009-127-04, 51009-830-94 - Packager: Tom's of Maine, 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 August 24, 2010
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- 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 physician. children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician - Inactive ingredients
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- PRINCIPAL DISPLAY PANEL - 119 g Tube
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INGREDIENTS AND APPEARANCE
CHILDRENS OUTRAGEOUS ORANGE MANGO
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-127 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium Monofluorophosphate 0.0076 g in 1 g Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Calcium carbonate (UNII: H0G9379FGK) Hydrated silica (UNII: Y6O7T4G8P9) Orange (UNII: 5EVU04N5QU) Carrageenan (UNII: 5C69YCD2YJ) sodium lauryl sulfate (UNII: 368GB5141J) Product Characteristics Color WHITE Score Shape Size Flavor ORANGE (Orange-mango with other natural fruit flavors) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51009-127-04 1 in 1 CARTON 1 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 08/30/2010 CHILDRENS OUTRAGEOUS ORANGE MANGO
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-830 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium Monofluorophosphate 0.0076 g in 1 g Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Calcium carbonate (UNII: H0G9379FGK) Hydrated silica (UNII: Y6O7T4G8P9) Orange (UNII: 5EVU04N5QU) Carrageenan (UNII: 5C69YCD2YJ) sodium lauryl sulfate (UNII: 368GB5141J) Product Characteristics Color WHITE Score Shape Size Flavor ORANGE (Orange-mango with other natural fruit flavors) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51009-830-94 119 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 08/30/2010 Labeler - Tom's of Maine, Inc. (052764354) Establishment Name Address ID/FEI Business Operations Tom's of Maine, Inc. 052764354 MANUFACTURE