Label: HEB EXTRA WHITENING- stannous fluoride paste, dentifrice
- NDC Code(s): 37808-171-12, 37808-171-19
- Packager: HEB
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
Stannous fluoride 0.454% (0.16% w/v fluoride ion)............Anticavity, AntisensitivityClose
- 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. Stop use and ask a dentist if the sensitivity problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care.
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, twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
Do not swallowClose
- DOSAGE & ADMINISTRATION
Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: ask a dentist.Close
- Other Information
Store in a cool dry place. Keep tube capped when not in use.Close
- Inactive ingredients
water, hydrated silica, glycerin, propylene glycol, PEG-6, sodium tripolyphosphate, zinc lactate, trisodium phosphate, monosodium phosphate, flavor, sodium lauryl sulfate, sodium gluconate, carrageenan, sodium saccharin, polyethylene, xanthanClose
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
HEB EXTRA WHITENING
fluoride paste, dentifrice
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37808-171 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.4540 g in 100 g Inactive Ingredients Ingredient Name Strength WATER ZINC LACTATE SACCHARIN SODIUM POLYETHYLENE GLYCOL 600 SODIUM PHOSPHATE, TRIBASIC SODIUM TRIPOLYPHOSPHATE SODIUM GLUCONATE PROPYLENE GLYCOL XANTHAN GUM HYDRATED SILICA GLYCERIN SODIUM PHOSPHATE CHONDRUS CRISPUS TITANIUM DIOXIDE SODIUM LAURYL SULFATE HIGH DENSITY POLYETHYLENE FD&C BLUE NO. 1 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:37808-171-19 1 in 1 CARTON 1 NDC:37808-171-12 170 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/01/2012 Labeler - HEB (007924756) Registrant - Lornamead (126440440) Establishment Name Address ID/FEI Business Operations Lornamead 126440440 manufacture(37808-171), pack(37808-171)