Label: XLEAR COUGH DROPS (GREEN APPLE)- menthol lozenge
- NDC Code(s): 27017-021-01
- Packager: Xlear Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 10, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- WARNINGS
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INGREDIENTS AND APPEARANCE
XLEAR COUGH DROPS (GREEN APPLE)
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:27017-021 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4 mg Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) MALIC ACID (UNII: 817L1N4CKP) STEVIA LEAF (UNII: 6TC6NN0876) ISOMALT (UNII: S870P55O2W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALFALFA (UNII: DJO934BRBD) Product Characteristics Color green Score score with uneven pieces Shape ROUND Size 22mm Flavor APPLE Imprint Code none Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:27017-021-01 30 in 1 BOX; Type 0: Not a Combination Product 12/12/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/12/2019 Labeler - Xlear Inc. (839884058) Establishment Name Address ID/FEI Business Operations Primrose Candy Company 005086855 manufacture(27017-021)