Label: HEB HEBUDDY- fluoride paste, dentifrice
- NDC Code(s): 37808-192-00, 37808-192-02
- Packager: HEB
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 22, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
Adults and children 2 years of age and older:brush teeth thoroughly 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.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HEB HEBUDDY
fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-192 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.15 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) 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) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color pink Score Shape Size Flavor WATERMELON (Watermelon mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-192-00 12 in 1 CASE 12/01/2012 02/20/2019 1 120 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:37808-192-02 120 g in 1 TUBE; Type 0: Not a Combination Product 12/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 12/01/2012 Labeler - HEB (007924756) Registrant - Lornamead Inc. (078584069) Establishment Name Address ID/FEI Business Operations Lornamead Inc. 080046418 manufacture(37808-192)