HEB EXTRA WHITENING- stannous fluoride paste, dentifrice 
HEB

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.

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Drug Facts

Active ingredient

Stannous fluoride 0.454% (0.16% w/v fluoride ion)............Anticavity, Antisensitivity

Uses

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.

Directions

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 swallow

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: ask a dentist.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

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, xanthan

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Carton label

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Tube Label

HEB  EXTRA WHITENING
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37808-171
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION0.4540 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINT (mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-171-191 in 1 CARTON
1NDC:37808-171-12170 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/01/2012
Labeler - HEB (007924756)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture(37808-171), pack(37808-171)

Revised: 1/2013
Document Id: 7f40fc97-a527-448b-858f-d5052a48160b
Set id: 936a08a1-f4cc-4299-9d93-30bb7d63c8c0
Version: 1
Effective Time: 20130108
 
HEB