2X MED LIQ- benzocaine liquid

2x Med Liq by

Drug Labeling and Warnings

2x Med Liq by is a Otc medication manufactured, distributed, or labeled by CSR Cosmetic Solutions, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine 20%

Menthol 0.1%

PURPOSE

Oral anesthetic

Oral anesthetic

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

2X MED LIQ 
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49354-375
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 mg  in 100 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	red (Red/Orange)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49354-375-08	1 in 1 CARTON	09/01/2021
1		14.7 mL in 1 BOTTLE, GLASS; 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	09/01/2021

Labeler - CSR Cosmetic Solutions (243501959)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
CSR Cosmetic Solutions		243501959	pack(49354-375) , manufacture(49354-375)