Label: PO SUM ON HEALING BALM- menthol ointment
- NDC Code(s): 54155-053-01, 54155-053-02, 54155-053-03
- Packager: PO SUM ON MEDICINE FACTORY LIMITED
- 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 August 22, 2019
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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 HEALING BALM
menthol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54155-053 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 13 g in 100 g Inactive Ingredients Ingredient Name Strength SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) YELLOW WAX (UNII: 2ZA36H0S2V) CINNAMON OIL (UNII: E5GY4I6YCZ) DAEMONOROPS DRACO RESIN (UNII: 787Z7N9UCU) GLYCYRRHIZA URALENSIS WHOLE (UNII: 8XW1DS8UIR) PEPPERMINT OIL (UNII: AV092KU4JH) PETROLATUM (UNII: 4T6H12BN9U) STEARIC ACID (UNII: 4ELV7Z65AP) CAMELLIA OIL (UNII: T1PE06G0VE) PARAFFIN (UNII: I9O0E3H2ZE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54155-053-02 1 in 1 BOX 05/25/2017 1 18 g in 1 JAR; Type 0: Not a Combination Product 2 NDC:54155-053-03 1 in 1 BOX 05/25/2017 2 10 g in 1 JAR; Type 0: Not a Combination Product 3 NDC:54155-053-01 1 in 1 PACKET 08/22/2019 3 3.5 g in 1 JAR; 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 05/25/2017 Labeler - PO SUM ON MEDICINE FACTORY LIMITED (664986395) Establishment Name Address ID/FEI Business Operations PO SUM ON MEDICINE FACTORY LIMITED 664986395 manufacture(54155-053)