Label: SHOPKINS BRUSH BUDDIES- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 71106-002-01 - Packager: Foshan Nanhai JiaChun Biology Engeneering Co., Ltd
- 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 11, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
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 until good habits are established.
Children under 2 years of age: Ask a dentist. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SHOPKINS BRUSH BUDDIES
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71106-002 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.4 mg in 100 g Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SORBITOL (UNII: 506T60A25R) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) WATER (UNII: 059QF0KO0R) .ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL (UNII: S8TT5K3C8Y) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) XYLITOL (UNII: VCQ006KQ1E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color blue (F D & C Blue #1) , red (FD &C Red #4) Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71106-002-01 119 g in 1 TUBE; Type 0: Not a Combination Product 01/11/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/11/2017 Labeler - Foshan Nanhai JiaChun Biology Engeneering Co., Ltd (527935253) Establishment Name Address ID/FEI Business Operations Foshan Nanhai JiaChun Biology Engeneering Co., Ltd 527935253 manufacture(71106-002)