NDC | 55312-003-01 |
Set ID | 082d3822-cd16-4394-9aca-e4753fd8e610 |
Category | HUMAN OTC DRUG LABEL |
Packager | Western Family Foods, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART355 |
- Active Ingredient
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
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
-
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)