NDC | 59321-055-01, 59321-055-02, 59321-055-03, 59321-055-04, 59321-055-05 |
Set ID | 17552943-4f11-42d6-ad41-fbc53f2bbd9a |
Category | HUMAN OTC DRUG LABEL |
Packager | GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- 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 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
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZHENG GU SHUI
camphor, menthol linimentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59321-055 Route of Administration PERCUTANEOUS, TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 5.6 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.6 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) POLYGONUM CUSPIDATUM WHOLE (UNII: 1VDG5Y5HS6) CYNANCHUM PANICULATUM ROOT (UNII: CZP7EPR012) ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759) WATER (UNII: 059QF0KO0R) ZEDOARY (UNII: 123C43G128) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59321-055-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/19/2000 2 NDC:59321-055-02 88 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 10/19/2000 3 NDC:59321-055-03 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/19/2000 4 NDC:59321-055-04 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/19/2000 5 NDC:59321-055-05 12 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/13/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/19/2000 Labeler - GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD (653862581) Establishment Name Address ID/FEI Business Operations GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD 653862581 manufacture(59321-055)