- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions:
Adults and children 2 years of age and older: Apply Level Toothpaste onto a soft bristle toothbrush. 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 in good brushing and rinsing habits (to minimize swallowing). Use a pea-sized amount. Supervise children as necessary until capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.
- INACTIVE INGREDIENT
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- DOSAGE FORMS & STRENGTHS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LEVEL ANTICAVITY
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50001-111 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 76 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) XYLITOL (UNII: VCQ006KQ1E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CALCIUM CARBONATE (UNII: H0G9379FGK) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SACCHARIN (UNII: FST467XS7D) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50001-111-50 141.7 g in 1 TUBE 2 NDC:50001-111-10 28.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part355 12/30/2009 Labeler - Level Oral Care, LLC (832019124) Establishment Name Address ID/FEI Business Operations AmLion Toothpaste Mfg. Sdn. Bhd. 652244161 manufacture