Label: PO SUM ON MEDICATED- menthol oil
- NDC Code(s): 54155-052-01, 54155-052-02
- Packager: PO SUM ON MEDICINE FACTORY LIMITED
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 10, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PO SUM ON MEDICATED
menthol oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54155-052 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 15 g in 100 mL Inactive Ingredients Ingredient Name Strength SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) GLYCYRRHIZA URALENSIS WHOLE (UNII: 8XW1DS8UIR) CINNAMON OIL (UNII: E5GY4I6YCZ) DAEMONOROPS DRACO RESIN (UNII: 787Z7N9UCU) PEPPERMINT OIL (UNII: AV092KU4JH) CAMELLIA OIL (UNII: T1PE06G0VE) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54155-052-01 1 in 1 CAN 05/10/2004 1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 2 NDC:54155-052-02 1 in 1 BOX 05/10/2004 2 5.6 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 part348 05/10/2004 Labeler - PO SUM ON MEDICINE FACTORY LIMITED (664986395) Establishment Name Address ID/FEI Business Operations PO SUM ON MEDICINE FACTORY LIMITED 664986395 manufacture(54155-052)