NDC | 63047-0002-1, 63047-0002-2, 63047-0002-3, 63047-0002-4 |
Set ID | c1632cd8-fe9a-408e-8624-d98efe3c4815 |
Category | HUMAN OTC DRUG LABEL |
Packager | MACAU-UNION PHARMACEUTICAL LTD |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- DO NOT USE
- WHEN USING
-
STOP USE
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- excessive irritation of the skin develops
- nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
- pain persists for more than 10 days
- redness is present
- in conditions affecting children under 12 years of age
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- INDICATIONS & USAGE
- WARNINGS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
WHITE FLOWER ANALGESIC BALM
camphor, menthol, methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63047-0002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 6 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 14.5 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 40.02 g in 100 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) LAVENDER OIL (UNII: ZBP1YXW0H8) PEPPERMINT OIL (UNII: AV092KU4JH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63047-0002-1 1 in 1 BOX 10/01/2018 1 20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 2 NDC:63047-0002-2 1 in 1 BOX 10/01/2018 2 10 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 3 NDC:63047-0002-3 1 in 1 BOX 10/01/2018 3 5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 4 NDC:63047-0002-4 1 in 1 BOX 10/01/2018 4 2.5 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 06/11/2010 Labeler - MACAU-UNION PHARMACEUTICAL LTD (448605614) Establishment Name Address ID/FEI Business Operations MACAU-UNION PHARMACEUTICAL LTD 448605614 manufacture(63047-0002) Establishment Name Address ID/FEI Business Operations HOE HIN PAK FAH YEOW MANUFACTORY LTD 686212961 manufacture(63047-0002)