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

Water, Sorbitol, Hydrated Silica, Glycerin, Peg-12, Cellulose Gum, Flavor, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Cocamidopropyl Betaine, FD&C 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 Type HUMAN OTC DRUG Item Code (Source) NDC:37808-167
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.243 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color pink Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37808-167-70 12 in 1 CASE
1 NDC:37808-167-72 119 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(37808-167) , pack(37808-167)

Revised: 1/2013
Document Id: 9338b577-c3b2-4f2e-b9c1-67d3494b6c7c
Set id: 2c972c65-34aa-4348-b997-c5e65a884575
Version: 1
Effective Time: 20130125
 
HEB