HEB HEBUDDY- sodium 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

Sodium Fluoride 0.24% ..................................Purpose: Anticavity

Uses

Helps protect against caviites

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children under 6 years of age.

Directions

Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Do not swallow

To minimize swallowing use a pea-sized amount in children under 6

Supervise childrens brushing until good habits are established

Children under 2 years of age: consult a dentist or doctor.

Other Information

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

Inactive ingredients

Sorbitol, Water, Hydrated Silica, Glycerin, Cellulose Gum, PEG-12, Flavor, Sodium Benzoate, Sodium Saccharin, Cocamidopropyl Betaine, Mica, Titanium Dioxide, Red 40

Adults and children 2 years of age and older: brush teeth throuoghly, preferably after every meal or at least twice a day, or as directed by a dentist or doctor.

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Tube label

HEB  HEBUDDY
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37808-192
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.243 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
WATER 
SODIUM BENZOATE 
SORBITOL 
TITANIUM DIOXIDE 
SACCHARIN SODIUM 
COCAMIDOPROPYL BETAINE 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 600 
CARBOXYMETHYLCELLULOSE SODIUM 
FD&C RED NO. 40 
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorWATERMELON (Watermelon mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-192-0012 in 1 CASE
1NDC:37808-192-02120 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(37808-192), pack(37808-192)

Revised: 1/2013
Document Id: 297c8aba-098c-4147-a984-f05b11c6354f
Set id: a6af1baf-17bf-428c-8744-1490359b0cfb
Version: 4
Effective Time: 20130125
 
HEB