Label: WESTERN FAMILY COMPLETE WHITENING- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 55312-003-01 - Packager: Western Family Foods, Inc
- 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 10, 2011
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- Official Label (Printer Friendly)
- Active Ingredient
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Adults and children Brush teeth throughly, preferably after
6 years and older each meal, or at least twice a day, or as
directed by your dentist. Do not swallow.Children between To minimize swallowing, use a pea-sized
6 and 12 years amount and supervise brushing until
good habits are established.Children under 6 years Ask a dentist or physician.
- Inactive Ingredients:
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
WESTERN FAMILY COMPLETE WHITENING
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-003 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride 2.43 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) ZINC CITRATE (UNII: K72I3DEX9B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARRAGEENAN (UNII: 5C69YCD2YJ) MICA (UNII: V8A1AW0880) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55312-003-01 181.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 11/24/2008 Labeler - Western Family Foods, Inc (192166072)