Label: HEB EXTRA WHITENING- fluoride paste, dentifrice
- NDC Code(s): 37808-961-12, 37808-961-19
- Packager: HEB
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Updated November 15, 2012
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- Active ingredients / Purpose
Potassium nitrate 5%....................................................Antihypersensitivity
Sodium fluoride 0.24% (0.15% w/v fluoride ion)............AnticavityClose
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
- aids in the prevention of dental cavities
When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. See your dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.Close
- DOSAGE & ADMINISTRATION
Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.Close
- Other Information
Store in a cool dry place. Keep tube capped when not in use.Close
- Inactive ingredients
cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gumClose
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
HEB EXTRA WHITENING
fluoride paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-961 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.24 g in 100 g POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5.0 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) HYDRATED SILICA (UNII: Y6O7T4G8P9) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) Product Characteristics Color Score Shape Size Flavor MINT (mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-961-19 1 in 1 CARTON 1 NDC:37808-961-12 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/20/2011 Labeler - HEB (007924756) Registrant - Lornamead (126440440) Establishment Name Address ID/FEI Business Operations Lornamead 126440440 manufacture(37808-961) , pack(37808-961)