HEB DRY MOUTH- sodium 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]

ACTIVE INGREDIENT

Active ingredient

Sodium Fluoride (0.15% w/v fluoride ion)

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Use

• aids in the prevention of dental cavities

WARNINGS

Warnings

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children 12 years of age and under. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years of age and older: Apply onto a soft bristle toothbrush.

• 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 physician.

Children under 12 years of age: consult a dentist or physician. Once recommended, to minimize swallowing for children under 6,use a pea sized amount and supervise brushing until good habits are established.

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide.

SPL UNCLASSIFIED SECTION

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

PRINCIPAL DISPLAY PANEL

H-E-B®

DRY MOUTH

FLUORIDE ANTICAVITY TOOTHPASTE

Fresh Mint

NET WT. 4.3 OZ (122g)

INGREDIENTS AND APPEARANCE

HEB  DRY MOUTH
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-331
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
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-331-39	1 in 1 CARTON	02/20/2019
1		122 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 final	part355	02/20/2019

Labeler - HEB (007924756)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(37808-331)