HEB MOUTH SORE RELIEF- benzalkonium chloride, benzocaine, zinc chloride gel

HEB Mouth Sore Relief by

Drug Labeling and Warnings

HEB Mouth Sore Relief 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

Benzalkonium chloride 0.02%

Benzocaine 20%

Zinc chloride 0.1%

PURPOSE

Purpose

Oral Antiseptic

Oral Pain Reliever

Oral Astringent

INDICATIONS & USAGE

Uses

temporarily relieves of pain caused by:

• canker sores
• cold sores
• fever blisters
• minor irritation of the mouth and gums
• to help protect against infection in minor oral irritation

WARNINGS

Warnings

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics

Do not use

• more than directed
• for more than 7 days unless told to do so by a dentist or doctor
• for teething
• in children under 2 years of age

Stop use and ask a doctor if

• swelling, rash, fever develops
• irritation, pain or redness persist or worsen
• sore mouth symptoms do not improve in 7 days
• allergic reaction occurs

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• cut open tip of tube on score mark
• adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor.
• children under 12 years of age should be supervised in the use of this product.
• children under 2 years of age: do not use

INACTIVE INGREDIENT

Inactive ingredients Allantoin,Carbomer, Edetate Disodium, Mentha Piperata (Peppermint Oil), Polyethylene Glycol, Polysorbate 60, Propylene Glycol, Propyl Gallate, Purified Water, PVP, Sodium Saccharin, Sorbic Acid, Stearyl Alcohol.

QUESTIONS

Questions or Comments? Call 1-877-777-2473

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MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

PRINCIPAL DISPLAY PANEL

H-E-B

MOUTH SORE RELIEF

FAST-ACTING GEL

TRIPLE MEDICATED

ORAL PAIN RELIEVER/ANTISEPTIC/ASTRINGENT

NET WT 0.42 OZ (11.9 g)

INGREDIENTS AND APPEARANCE

HEB MOUTH SORE RELIEF 
benzalkonium chloride, benzocaine, zinc chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-312
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.02 g  in 100 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALLANTOIN (UNII: 344S277G0Z)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)
PEPPERMINT OIL (UNII: AV092KU4JH)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics
Color	white (white/clear to yellow to slight pink/orange)	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-312-29	1 in 1 CARTON	02/19/2019
1		11.9 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	02/19/2019

Labeler - HEB (007924756)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(37808-312)