Label: ZHENG GU SHUI- camphor, menthol liniment
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NDC Code(s):
59321-055-01,
59321-055-02,
59321-055-03,
59321-055-04, view more59321-055-05
- Packager: GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 13, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
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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
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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)