ZHENG GU SHUI- camphor, menthol liniment 
GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD

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.

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DRUG FACTS

Active Ingredients
Camphor 5.6%
Menthol 5.6%

Purpose
External Analgesic
External Analgesic

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
simple backache
arthritis
strains
bruises
sprains

Warnings
For external use only

Flammable
Keep away from fire or flame

When using this product
avoid contact with the eyes and mucous membranes
do not bandage tightly

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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: Do not use, consult a doctor.

Other Information
keep container tightly closed
store at room temperature under 86°F (30°C)

Inactive Ingredients
Alcohol, Japanese knotweed (Polygonum cuspidatum Siebold & Zucc.) rhizome, paniculate swallowwort [Pycnostelma paniculatum (Bge.) K. Schum.] root, shin-leaf prickly ash [Zanthoxylum nitidum (Roxb.) DC.] root, water, zedoary rhizome.

Questions or Comments? (888) 221-3496 M-F 9 am to 5 pm

ZHENG GU SHUI

NDC 59321-055-01

EXTERNAL ANALGESIC LOTION

3.4 FL OZ (100 mL)
Box1

ZHENG GU SHUI 
camphor, menthol liniment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59321-055
Route of AdministrationPERCUTANEOUS, TRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5.6 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59321-055-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/19/2000
2NDC:59321-055-0288 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/19/2000
3NDC:59321-055-0360 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/19/2000
4NDC:59321-055-0430 mL in 1 BOTTLE; Type 0: Not a Combination Product10/19/2000
5NDC:59321-055-0512 mL in 1 BOTTLE; Type 0: Not a Combination Product12/13/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/19/2000
Labeler - GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD (653862581)
Establishment
NameAddressID/FEIBusiness Operations
GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD653862581manufacture(59321-055)

Revised: 12/2017
Document Id: 6ada155e-94c3-4f5e-a1bc-217fd94915d4
Set id: 17552943-4f11-42d6-ad41-fbc53f2bbd9a
Version: 2
Effective Time: 20171213
 
GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD