HEB HEBUDDY- fluoride paste, dentifrice

HEB by

Drug Labeling and Warnings

HEB by is a Otc medication manufactured, distributed, or labeled by HEB, Lornamead Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredient

Sodium Fluoride 0.243%

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Use Helps protect against cavities

WARNINGS

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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

Other information

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

INACTIVE INGREDIENT

Inactive ingredients sorbitol, water, hydrated silica, glycerin, cellulose gum, PEG-12, flavor, sodium benzoate, sodium saccharin, cocamidopropyl betaine, mica, titanium dioxide, red 40

QUESTIONS

Questions? Call 1-877-777-2743

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MADE WITH PRIDE AND CARE FOR H-E-B,

SAN ANTONIO, TX 78204

MADE IN USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEB  HEBUDDY
fluoride paste, dentifrice

Product 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	0.243 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 final	part355	12/01/2012

Labeler - HEB (007924756)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(37808-192)