NDC | 48256-0041-1, 48256-0041-2, 48256-0041-3 |
Set ID | 65282267-de63-453a-a686-f8752c71b9ef |
Category | HUMAN OTC DRUG LABEL |
Packager | HOE HIN PAK FAH YEOW MANUFACTORY LTD |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
-
STOP USE
Stop use and ask a doctor if
- condition worsens
- symptoms persis for more than 7 days
- symptoms clear up and occur again within a few days
- excessive irritation develops
- nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
- when using for pain of arthritis:
- 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
Directions
- adults and children 3 years of age and older: apply on the affected area not more than 3 to 4 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage gently.
- children under 3 years of age: do not use, consult your physician
- refer to the above warnings; use otherwise than as directed may be dangerous
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
WHITE FLOWER STRAIN RELIEF
camphor, menthol and methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48256-0041 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 10.2 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 15.3 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 49.1 g in 100 mL Inactive Ingredients Ingredient Name Strength .BETA.-CAROTENE (UNII: 01YAE03M7J) CHINESE CINNAMON OIL (UNII: A4WO0626T5) D&C GREEN NO. 6 (UNII: 4QP5U84YF7) D&C RED NO. 17 (UNII: ND733RX3JN) EUCALYPTUS OIL (UNII: 2R04ONI662) LAVENDER OIL (UNII: ZBP1YXW0H8) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48256-0041-1 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/07/2012 2 NDC:48256-0041-2 25 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/07/2012 3 NDC:48256-0041-3 3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/07/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/07/2012 Labeler - HOE HIN PAK FAH YEOW MANUFACTORY LTD (686359001) Establishment Name Address ID/FEI Business Operations HOE HIN PAK FAH YEOW MFY LTD 686212961 manufacture(48256-0041)