4X MEDICATED TOOTHACHE AND GUM CREAM- benzocaine 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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5820611 4x Med Cream

Active ingredients Purpose

Benzalkonium chloride 0.13% . . . Oral antiseptic

Benzocaine 20% . . . . . . . . . . . . . Oral pain reliever

Menthol 0.26% . . . . . . . . . . . . . . .Oral pain reliever

Zinc chloride 0.15% . . . . . . . . . . .Oral astringent

Use

for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation

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 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 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 * cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amoutn of product to the cavity and around the gum surrounding the teeth. Use 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

Other information * do not use if tip is cut prior to opening ( this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted ( do not use continuously * this formula will stay in place for extended duration of relief * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide

Carton Artwork

4X MEDICATED TOOTHACHE AND GUM CREAM 
benzocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-116
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.15 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.25 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBIC ACID (UNII: X045WJ989B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Colorwhite (Cloudy) Score    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-116-691 in 1 CARTON06/02/2020
19.4 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 finalpart35606/02/2020
Labeler - HEB (007924756)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(37808-116)

Revised: 6/2020
Document Id: a71c5259-cbd0-7566-e053-2995a90a2cb6
Set id: a71c5259-cbcf-7566-e053-2995a90a2cb6
Version: 1
Effective Time: 20200602
 
HEB