Active Ingredients
Camphor 4.28%
Menthol 2.84%
Methyl Salicylate 1.4%
Shennong Analgesic Plaster
FDA Label NDC 68048-922
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Zhanjiang Jimin Pharmaceutical Co. Ltd for the product Shennong Analgesic Plaster (NDC 68048-922). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Camphor External Analgesic
Menthol External Analgesic
Methyl Salicylate 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.
Do not use on pregnant woman.
Do Not Use
on wounds, irritated or damaged skin, otherwise than as directed.
When Using This Product
Avoid contact with the eyes or 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 of the skin develops.
Nausea, vomiting, abdominal discomfort, diarrhea or skin rash occurs.
When using for pain of arthritis: pain persists for more than 10 days and if redness is present.
Keep Out Of Reach Of Children.
Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Clean and dry the affected area. Remove the paper backing from the plaster. Apply the plaster to the affected area. Change plasters as needed, but do not apply more than 3 to 4 times daily.
Children under 12 years of age: contact a doctor.
Other Information
Keep tightly closed.
Store at room temperature, 20 to 25 °C (68-77 °F)
Inactive Ingredients
PANAX PSEUDOGINSENG ROOT, ANGELICA DAHURICA ROOT, CIBOTIUM BAROMETZ ROOT, NOTOPTERYGIUM INCISUM ROOT, SAPOSHNIKOVIA DIVARICATA ROOT, ACTAEA CIMICIFUGA ROOT, SAFFLOWER, LIGUSTICUM WALLICHII ROOT, ANGELICA SINENSIS ROOT, MYRRH, PARIS POLYPHYLLA WHOLE, FRANKINCENSE, BASIL OIL, ATROPA BELLADONNA, NATURAL LATEX RUBBER, ROSIN, ZINC OXIDE, PETROLATUM, LANOLIN
Drug Facts
Image Description (Carton)
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