Active Ingredient
Menthol 16%
Methyl salicylate 30%
Medicated Green Oil
FDA Label NDC 55531-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allways Health-care Corporation Limited for the product Medicated Green Oil (NDC 55531-001). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with
simple backache
arthritis
strains
sprains
Warnings
For external use only. Avoid contact with the eyes or mucus membranes.
Do Not Use
other than as directed.
When Using This Product
do not apply to wounds or damaged skin
do not bandage tightly
Stop Use And Ask A Doctor
if condition worsenes
symptoms persist for more than 7 days or clear up and occur again within a few days.
excessive irritation of the skin develops.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact Poison Control Center right away.
Directions
Adulst and children 3 years of age and older: Apply to the affected area not more than 3 to 4 times daily. For children under 3 years of age, consult a doctor.
Other Information
keep in a cool and dry place.
Store at an average temperature of 86degrees F (30C)
Inactive Ingredients
Eucalyptus oil, fragrance, mineral oil
Other
DISTRIBUTED BY: NATIONAL HEALTH CARE CORPORATION
FOUNTAIN VALLEY, CA 92708 U.S.A.
MADE IN HONG KONG
TO REPORT A SERIOUS ADVERSE EVENT CONTACT
1-213-618-6868
Product Label
Label (Label)
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