NDC | 49980-003-01, 49980-003-26 |
Set ID | e1480d87-61ff-4af2-b362-6fe74c636b63 |
Category | HUMAN OTC DRUG LABEL |
Packager | Hong Kong Zihua Pharmaceutical Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- Active Ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Inactive ingredients
- Package Label
-
INGREDIENTS AND APPEARANCE
ZIHUA EMBROCATION COOLING PAIN RELIEF
camphor menthol methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49980-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 11 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 15 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15 g in 100 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) LAVENDER OIL (UNII: ZBP1YXW0H8) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49980-003-01 1 in 1 BOX 1 NDC:49980-003-26 26 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/15/2014 Labeler - Hong Kong Zihua Pharmaceutical Ltd. (663989580) Establishment Name Address ID/FEI Business Operations Hong Kong Zihua Pharmaceutical Ltd. 663989580 manufacture(49980-003)