Label: CHLORASEPTIC MAX- menthol and benzocaine lozenge
- NDC Code(s): 67172-114-61
- Packager: Prestige Brands Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 12, 2024
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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.
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INGREDIENTS AND APPEARANCE
CHLORASEPTIC MAX
menthol and benzocaine lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-114 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 15 mg Inactive Ingredients Ingredient Name Strength CORN SYRUP (UNII: 9G5L16BK6N) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color red Score 2 pieces Shape OVAL Size 4mm Flavor BERRY (Wild berries) Imprint Code C Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67172-114-61 1 in 1 CARTON 08/01/2010 1 15 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 Drug M022 08/01/2010 Labeler - Prestige Brands Holdings, Inc. (159655021)