Uses
For the temporary relief of minor aches and pains of muscles and joints, associated with simpled backache, arthritis, strains, bruises and sprains.
Methyl Salicylate 25% Cream
FDA Label NDC 85477-311
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Methyl Salicylate 25% (NDC 85477-311). 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 uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
For external use only.
Do not used on damaged or broken skin.
Otc - When Using
When using this product
- Avoid contact with the eyes
- Do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
- rash or irritation develops and lasts
- condition worsens
- if symptoms persist more than 7 days or clear up and occur again in a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If swallowed get medical help or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
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, consult a doctor.
Storage And Handling
Protect the product in this container from excessive heat and direct sun.
Otc - Active Ingredient
Methyl Salicylate 25%
Inactive Ingredient
Arnica Montana Extract, Cetearly Alcohol, Dimethyl Sulfone, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Isostearyl Palmitate, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Silica, Sodium Chondroitin Sulfate, Sodium Polyacrylate, Stearic Acid, Triethanolamine, Water
Purpose
Topical Analgesic
Package Label.Principal Display Panel
Label (Methyl120g)
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