Label: 2X MED LIQ- benzocaine liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 49354-375-58 - Packager: CSR Cosmetic Solutions
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 2, 2021
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
2X MED LIQ
benzocaine liquidProduct 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:49354-375-58 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)
