HEB EXTRA WHITENING- fluoride paste, dentifrice

HEB by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients / Purpose

Potassium nitrate 5%....................................................Antihypersensitivity

Sodium fluoride 0.15% w/v fluoride ion.........................Anticavity

Uses

• aids in reducing sensitivity
• aids in the prevention of dental cavities

WARNINGS

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. See your dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth. Do not swallow.

DOSAGE & ADMINISTRATION

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

Other Information

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

Inactive ingredients

cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

HEB  EXTRA WHITENING
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-861
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 g  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)

Product Characteristics
Color	white (white to light tan)	Score
Shape		Size
Flavor	MINT (mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-861-19	1 in 1 CARTON	11/30/2012
1	NDC: 37808-861-12	113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/20/2011

Labeler - HEB (007924756)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		078584069	manufacture(37808-861) , pack(37808-861)