Otc - Active Ingredient
Active Ingredients
Camphor 5.6%
Menthol 5.6%
Zheng Gu Shui Liniment
FDA Label NDC 59321-055
13 label sections · Submitted to the FDA by Guangxi Yulin Pharmaceutical Group Co Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangxi Yulin Pharmaceutical Group Co Ltd for the product Zheng Gu Shui (NDC 59321-055). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
External Analgesic
External Analgesic
Indications & Usage
Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
■ arthritis
■ strains
■ bruises
■ sprains
■ simple backache
Warnings
Warnings
For external use only
Flammable
Keep away from fire or flame
Otc - When Using
When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
Otc - 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of childrento avoid accidental poisoning.
If swallowed, get medical hep or contact a Poison Control Center right away.
Adverse Reactions
Report any unexpected side effectsfrom the use of this product to the FDA MedWatch Program.
Dosage & Administration
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 no use or consult a doctor.
Storage And Handling
Other information
■ keep container tightly closed
■ store at room temperature under 86°F (30°C)
Inactive Ingredient
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.
Otc - Questions
Questions or Comments? (888) 221-3496M-F 9 am to 5 pm
Package Label.Principal Display Panel
ZHENG GU SHUI
NDC 59321-055-01
EXTERNAL ANALGESIC LOTION
3.4 FL OZ (100 mL)
Image Of Carton (Box1)
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