2X MED LIQ- benzocaine liquid 
Lornamead

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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8015275 2x Med Liq

Benzocaine 20%

Menthol 0.1%

Oral anesthetic

Oral anesthetic

temporarily relieves pain associated with the following mouth and gum irritations: * toothache * sore gums * canker sores * braces * minor dental procedures

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated prompty 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.

Adults and children 2 years of age and older: * apply to affected area using applicator tip * 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

do not use if package has been opened * store ar 20-25°C (68-77°F)

alcohol, flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5

Example Card

2X MED LIQ 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62721-5375
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 mg  in 100 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Colorred (Red/Orange) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62721-5375-91 in 1 CARTON09/01/2021
114.7 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/01/2021
Labeler - Lornamead (126440440)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
CSR Cosmetic Solutions243501959pack(62721-5375) , manufacture(62721-5375)

Revised: 9/2021
Document Id: caf06d14-1843-a8c2-e053-2a95a90a2c65
Set id: caf06d14-1842-a8c2-e053-2a95a90a2c65
Version: 1
Effective Time: 20210901
 
Lornamead