Label: HONIBE- menthol lozenge
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Contains inactivated NDC Code(s)
NDC Code(s): 50788-001-01, 50788-001-02 - Packager: Island Abbey Foods Ltd.
- 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 June 27, 2012
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- ACTIVE INGREDIENT
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- PURPOSE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
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INGREDIENTS AND APPEARANCE
HONIBE
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50788-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 8.6 mg in 2.5 g Inactive Ingredients Ingredient Name Strength HONEY (UNII: Y9H1V576FH) EUCALYPTUS OIL (UNII: 2R04ONI662) Product Characteristics Color yellow (honey yellow) Score no score Shape ROUND (Lozenge) Size 16mm Flavor LEMON (LEMON OIL) Imprint Code raised;flower Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50788-001-02 1 in 1 BAG 1 NDC:50788-001-01 25 g in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/30/2012 Labeler - Island Abbey Foods Ltd. (243869661) Establishment Name Address ID/FEI Business Operations Island Abbey Foods Ltd. 243869661 manufacture
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