Label: CHLORASEPTIC- menthol and benzocaine lozenge
- NDC Code(s): 67172-021-18
- Packager: Prestige Brands Holdings, Inc.
- 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 May 24, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each lozenge)
- Purpose
- Uses
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Warnings
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. If a skin reaction occurs, stop use and seek medical help right away.
Sore Throat Warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 6 years of age unless directed by a doctor.
- pale, gray, or blue colored skin (cyanosis)
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHLORASEPTIC
menthol and benzocaine lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-021 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 6 mg Inactive Ingredients Ingredient Name Strength CORN SYRUP (UNII: 9G5L16BK6N) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) Product Characteristics Color red Score no score Shape OVAL Size 4mm Flavor CHERRY Imprint Code C Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67172-021-18 1 in 1 CARTON 08/01/2010 1 18 in 1 BLISTER PACK; 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 08/01/2010 Labeler - Prestige Brands Holdings, Inc. (159655021)