Label: SKYLINE HERBALS- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 80239-9138-6 - Packager: SKYLINE HERBALS PRIVATE LIMITED
- 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 31, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Use
- Warning
- Warning
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Directions
- Do not swallow
- Supervise children as necessary until capable of using without supervision
- Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
- Adults and children 6 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 under 6 years of age: Do not use unless directed by a dentist or physician
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 43 g Tube Carton
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INGREDIENTS AND APPEARANCE
SKYLINE HERBALS
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80239-9138 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 7.6 mg in 1 g Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SACCHARIN SODIUM (UNII: SB8ZUX40TY) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80239-9138-6 43 g in 1 TUBE; Type 0: Not a Combination Product 07/23/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/23/2019 Labeler - SKYLINE HERBALS PRIVATE LIMITED (877566114)