Label: GELATO NEUTRAL PH- sodium fluoride aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 68400-138-04 - Packager: Deepak Products, inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated August 11, 2011
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INGREDIENTS AND APPEARANCE
GELATO NEUTRAL PH
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68400-138 Route of Administration DENTAL, TOPICAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.5 g in 125 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLOXAMER 407 (UNII: TUF2IVW3M2) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) TROLAMINE (UNII: 9O3K93S3TK) PHOSPHORIC ACID (UNII: E4GA8884NN) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) XYLITOL (UNII: VCQ006KQ1E) HYDROFLUORIC ACID (UNII: RGL5YE86CZ) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) DMDM HYDANTOIN (UNII: BYR0546TOW) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68400-138-04 125 g in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/11/2011 Labeler - Deepak Products, inc. (124886743) Establishment Name Address ID/FEI Business Operations Deepak Products, inc. 124886743 manufacture