NDC | 63255-121-01, 63255-121-02 |
Set ID | 8ca80429-57dd-4e14-8334-cae87f55b836 |
Category | HUMAN OTC DRUG LABEL |
Packager | HYSAN PHARMACEUTICAL CO LTD |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HYSAN HUA TUO HUO LU
methyl salicylate, camphor (synthetic) oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63255-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 37 g in 100 mL CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 10 g in 100 mL Inactive Ingredients Ingredient Name Strength MENTHOL (UNII: L7T10EIP3A) TURPENTINE OIL (UNII: C5H0QJ6V7F) EUCALYPTUS OIL (UNII: 2R04ONI662) LAVENDER OIL (UNII: ZBP1YXW0H8) TOLU BALSAM (UNII: TD2LE91MBE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63255-121-01 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/01/2017 2 NDC:63255-121-02 3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2017 Labeler - HYSAN PHARMACEUTICAL CO LTD (666427133) Establishment Name Address ID/FEI Business Operations HYSAN PHARMACEUTICAL CO LTD 666427133 manufacture(63255-121)