Label: ESSENTIALS WHITEN AND STRENGTHEN- sodium fluoride 0.24% paste, dentifrice
- NDC Code(s): 10237-672-09, 10237-672-43
- Packager: Church & Dwight Co., 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 January 19, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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Directions
- do not swallow
- supervise children as necessary until capable of using without supervision
- rinse away toothpaste residue thoroughly after brushing
adults and children 2 years and older - brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 years - instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years - ask a dentist or physician
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ESSENTIALS WHITEN AND STRENGTHEN
sodium fluoride 0.24% paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-672 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.4 mg in 1 g Inactive Ingredients Ingredient Name Strength XANTHAN GUM (UNII: TTV12P4NEE) HYDRATED SILICA (UNII: Y6O7T4G8P9) CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505) SODIUM CARBONATE (UNII: 45P3261C7T) POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BICARBONATE (UNII: 8MDF5V39QO) METHYL SALICYLATE (UNII: LAV5U5022Y) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) Product Characteristics Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-672-43 1 in 1 CARTON 12/01/2019 1 121 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-672-09 1 in 1 CARTON 12/01/2019 2 25 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 12/01/2019 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 manufacture(10237-672)
