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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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HEB Mouth Sore Relief Triple Med Gel

Drug Facts

Active ingredient

Benzalkonium chloride 0.02%

Benzocaine 20%

Zinc chloride 0.1%

Purpose

Oral Antiseptic

Oral Pain Reliever

Oral Astringent

Uses

temporarily relieves of pain caused by:

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:

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.

Directions

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 or Comments? Call 1-877-777-2473

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

H-E-B

MOUTH SORE RELIEF

FAST-ACTING GEL

TRIPLE MEDICATED

ORAL PAIN RELIEVER/ANTISEPTIC/ASTRINGENT

NET WT 0.42 OZ (11.9 g)

HEB MOUTH SORE GEL 2821343-1R2

HEB MOUTH SORE RELIEF 
benzalkonium chloride, benzocaine, zinc chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.02 g  in 100 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (white/clear to yellow to slight pink/orange) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-312-291 in 1 CARTON02/19/2019
111.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/19/2019
Labeler - HEB (007924756)
Registrant - Lornamead Inc. (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.080046418manufacture(37808-312)

Revised: 1/2023
Document Id: f202ed09-ce2d-6f27-e053-2a95a90ad894
Set id: 8246a419-f8b1-4d99-e053-2991aa0ac4ac
Version: 10
Effective Time: 20230111
 
HEB