Label: BRUSHBUDDIES BARBIE ANTICAVITY FLUORIDETOOTH- sodium monofluorophosphate paste, dentifrice
-
Contains inactivated NDC Code(s)
NDC Code(s): 71106-003-01 - Packager: Foshan Nanhai Jiachun Biology Engineering Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
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 2, 2018
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions:
- 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.
- Do not swallow
- To minimize swallowing use a pea-sized amount in children under 6 years of age,
- Supervise children's brushing untill good habits are established.
Children under 2 years of age:
- Ask a dentist
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BRUSHBUDDIES BARBIE ANTICAVITY FLUORIDETOOTH
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71106-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) XYLITOL (UNII: VCQ006KQ1E) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM BENZOATE (UNII: OJ245FE5EU) XANTHAN GUM (UNII: TTV12P4NEE) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71106-003-01 119 g in 1 TUBE; Type 0: Not a Combination Product 08/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 08/02/2018 Labeler - Foshan Nanhai Jiachun Biology Engineering Co., Ltd. (527935253) Establishment Name Address ID/FEI Business Operations Foshan Nanhai JiaChun Biology Engineering Co., Ltd 527935253 manufacture(71106-003)