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| Product NDC Code | 59321-055 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Zheng gu shui |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | PERCUTANEOUS, TRANSDERMAL | ||||||||||||
| Dosage Form | LINIMENT | ||||||||||||
| RxCUI drug identifier | 1366315 | ||||||||||||
| Application Number | part348 | ||||||||||||
| Labeler Name | GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD | ||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Camphor 5.6% Menthol 5.6%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the temporary relief of minor aches and pains of muscles and joints due to: simple backache arthritis strains bruises sprains
Purpose
Information about the drug product’s indications for use.Purpose External Analgesic External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.ZHENG GU SHUI CAMPHOR, MENTHOL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL MENTHOL ALCOHOL POLYGONUM CUSPIDATUM WHOLE CYNANCHUM PANICULATUM ROOT ZANTHOXYLUM NITIDUM ROOT WATER ZEDOARY
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.ZHENG GU SHUI NDC 59321-055-01 EXTERNAL ANALGESIC LOTION 3.4 FL OZ (100 mL) Box1
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? (888) 221-3496 M-F 9 am to 5 pm
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with the eyes and mucous membranes do not bandage tightly
Storage and handling
Information about safe storage and handling of the drug product.Other Information keep container tightly closed store at room temperature under 86°F (30°C)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Flammable Keep away from fire or flame
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API