Active Ingredient
Methyl Salicylate 10%
Germa Linimento Ubre Plus Ointment
FDA Label NDC 73635-5800
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Germa Products, Llc for the product Germa Linimento Ubre Plus (NDC 73635-5800). 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, uses, purpose, warnings, if pregnant or breastfeeding, stop use and ask a doctor immediately if, other information, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For the temporary relief of minor aches and pains of muscles and joints.
Purpose
Topical Analgesic
Warnings
For external use only ■ Use only as directed
KEEP OUT OF THE REACH OF CHILDREN
In case of an overdose, call a Poison Control center or get medical help right away.
If Pregnant Or Breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Stop Use And Ask A Doctor Immediately If
pain persists for more than 7 days, or redness is present, or in conditions affecting children under 12 years of age • excessive irritation of the skin develops • if prone to allergic reaction from any of the ingredients.
Other Information
Store at controlled room temperature 15-30°C (59-86°F)
Directions
Use only as directed. Adults and children 2 years and older; apply to the affected area no more than 3 to 4 times daily n Children under 2 years of age; consult a physician.
Inactive Ingredients
Capsaicin, Glyceryl Monoisostearate, Isothiazolinone, Menthol Crystals, Mineral Oil, MSM, Propylene Glycol, and Stearic Acid.
When Using This Product
Avoid contact with eyes • Do not bandage tightly • Do not apply to wounds or broken skin • If the condition worsens and if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
Package Label.Principal Display Panel
Linimento Ubre Plus Cream (Linimento Ubre Plus Cream)
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