NDC | 53567-0972-3, 53567-0972-4, 53567-0972-8 |
Set ID | 66b18296-6c56-44d6-8c5f-6a83f5db8535 |
Category | HUMAN OTC DRUG LABEL |
Packager | Robell Research, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART355 |
- Active Ingredient:
- Purpose:
- Uses:
- Warnings:
- KEEP OUT OF REACH OF CHILDREN
-
Directions:
For best results: Brush teeth thoroughly after each meal, at least twice a day, or as directed by a dentist. Instruct children under six about good brushing and rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision. Under two years of age consult a dentist or a doctor before use.
- Inactive Ingredients:
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
SUPERSMILE
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53567-0972 Route of Administration DENTAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) SODIUM BICARBONATE (UNII: 8MDF5V39QO) CALCIUM CARBONATE (UNII: H0G9379FGK) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CALCIUM PEROXIDE (UNII: 7FRO2ENO91) SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM CARBONATE (UNII: 0E53J927NA) SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color Score Shape Size Flavor ORANGE (MANDARIN MINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53567-0972-3 1 in 1 BOX 07/14/2014 1 119 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:53567-0972-4 14.2 g in 1 TUBE; Type 0: Not a Combination Product 07/14/2014 3 NDC:53567-0972-8 40 g in 1 TUBE; Type 0: Not a Combination Product 07/14/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/14/2014 Labeler - Robell Research, Inc. (155571656)