HEB BRILLIANT WHITE- 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Sodium Monofluorophosphate 0.76% w/w (0.15% w/v fluoride ion)

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Uses aids in the prevention of dental caviites

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 thorughly preferably after each meal or at least twice per day, or as directed by a dentist or doctor.

• Instruct children under 6 years of age in good brushing and rinsing habits (to avoid swallowing).
• Supervise children as necessary until capable of using without supervision.
• Children under 2 years of age: consult a dentist or doctor.

INACTIVE INGREDIENT

Inactive ingredients glycerin, dicalcium phosphate, propylene glycol, PEG-12, PVP, silica, PEG/PPG 116/66 copolymer, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, hydrogen peroxide, etidronic acid, butylated hydroxytoluene, sodium saccharin, sucralose, phosphoric acid, water

STORAGE AND HANDLING

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

QUESTIONS

Questions or comments? CALL 1-877-777-2743

SPL UNCLASSIFIED SECTION

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

PRINCIPAL DISPLAY PANEL

H-E-B®

Dazzling Mint

BRILLIANT WHITE

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT. 5 OZ (141.7 g)

INGREDIENTS AND APPEARANCE

HEB  BRILLIANT WHITE
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-896
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)
PHOSPHORIC ACID (UNII: E4GA8884NN)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
ETIDRONIC ACID (UNII: M2F465ROXU)
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (L Menthol)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-896-69	1 in 1 CARTON	10/01/2012	02/21/2019
1		156 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 37808-896-29	1 in 1 CARTON	02/21/2019
2		141.7 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	10/01/2012

Labeler - HEB (007924756)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(37808-896)