Yan Ji Huo Jin Tou Gu Gao
FDA Label NDC 72183-769
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Maxam for the product Yan Ji Huo Jin Tou Gu Gao (NDC 72183-769). 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 drug facts, active ingredients, purpose, uses, warnings:, keep out of reach of children, directions:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Menthol 4%
Purpose
Topical Analgesic
Uses
Temporary relief minor aches and pains of muscles and joints associated with:
• Arthritis • Bruises • Simple backache • Strains • Sprains
Warnings:
For external use only
When using this product
• use only as directed
• avoid contact with eyes, mucous membranes or rashes
• do not apply to broken, wounded or damaged skin
• do not bandage or cover with any type of wrap except clothing
• do not use with a heating pad or apply external heat
• discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower
Stop use and ask a doctor if
• rash, itching or excessive skin irritation develops
• condition worsens or does not improve after regular use
• symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately
Directions:
Adult and children over 12 years of age:
• clean and dry affected area
• open pouch and remove patch, if desired, cut patch to size
• peel off protective backing and apply sticky side to affected area
• apply to affected area not more than 3 times daily
• remove patch from the skin before a maximum 8 hours application.
Children under 12 years of age
• consult a doctor before use
Inactive Ingredients:
Clematis Chinensis Root, Momordica Cochinchinensis Seed, Ricinus Communis Seed, Myrrh, Frankincense, Rosin, Yellow Wax, Zinc Oxide, Methyl Salicylate, FD&C Yellow #5 (a colorant), Indigo Carmine (a colorant), Sesame Oil
Other Information:
• This product may cause allergic reaction in some individuals.
• store in cool dry place and avoid direct sunlight
• keep patches tightly closed in the zip lock bag
Other
EXTERNAL PAIN RELIEVING PATCH
Elastic Patch
HERBAL PATCH
Product of Taiwan
US Distributor:
MAXAM, Hayward, CA 94545
MAXAM, PO Box 888, Newark, CA 94560
email:[email protected]
Packaging
Image Description (Label)
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