HEB SEVERE TOOTHACHE AND GUM RELIEF  TRIPLE MEDICATED- benzalkonium chloride, benzocaine, menthol cream 
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 Severe Toothache & Gum Relief Triple Medicated Cream

Drug Facts

Active ingredients

Benzocaine 20%

Menthol 0.25%

Benzalkonium Chloride 0.1%

Purpose

Oral pain reliever

Oral pain reliever

Antiseptic

Use

Warnings

Methemoglobenemia 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 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 or fever develops
  • irritation, pain or redness persists or worsens
  • 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

Other information

Inactive ingredientscellulose gum, gelatin, methyl salicylate, mineral oil, pectin, polyethylene glycol, sodium saccharin

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

H-E-B®

LONG LASTING CREAM

SEVERE TOOTHACHE & GUM RELIEF

ORAL PAIN RELIEVER

ANTISEPTIC

TRIPLE MEDICATED

NET WT 0.33 OZ (9.3 g)

HEB Severe TA-GumRelief Cream 2821353R1

HEB SEVERE TOOTHACHE AND GUM RELIEF   TRIPLE MEDICATED
benzalkonium chloride, benzocaine, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-313
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PECTIN (UNII: 89NA02M4RX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-313-491 in 1 CARTON02/20/2019
19.3 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 finalpart35602/20/2019
Labeler - HEB (007924756)
Registrant - Lornamead Inc. (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.080046418manufacture(37808-313)

Revised: 1/2023
Document Id: f2030113-fc98-6bee-e053-2995a90a10f6
Set id: 82586cb7-797c-e239-e053-2a91aa0af79c
Version: 10
Effective Time: 20230111
 
HEB