Label: SPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 42288-000-04 - Packager: SLH Optimal Health LLC
- 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 October 4, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Spearmint and Peppermint PLAQUE A WAY Fluoride Anticavity Toothpaste Gentle Formula
- Active Ingredient
- Purpose
- Use
- Warnings
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Directions
adults and children 2 years and over
Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
children under 6 years of age
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 a supervision.
children under 2 years of age
Consult a dentist or doctor.
- Inactive Ingredients
- Spearmint and Peppermint PLAQUE A WAY Fluoride Anticavity Toothpaste Gentle Formula 116g (42288-000-04)
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INGREDIENTS AND APPEARANCE
SPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42288-000 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.24 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) BIXA ORELLANA SEED (UNII: O87354RZ5A) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color Score Shape Size Flavor SPEARMINT (SPEARMINT) , PEPPERMINT (PEPPERMINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42288-000-04 116 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/03/2012 Labeler - SLH Optimal Health LLC (031081015) Registrant - SLH Optimal Health LLC (031081015) Establishment Name Address ID/FEI Business Operations SLH Optimal Health LLC 031081015 manufacture(42288-000)