Otc - Active Ingredient
Trolamine Salicylate 10%
Arthritis Relief Cream
FDA Label NDC 50804-207
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn, Inc for the product Arthritis Relief (NDC 50804-207). 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 otc - active ingredient, otc - purpose, dosage & administration, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Dosage & Administration
Temporarily relieves minor pain associated with arthritis, simple backache, muscle strain, sprains, bruises, cramps.
Warnings
For external use only.
Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
When using this product use only as directed, avoid taking a bath or shower within 1 hour before or after applying, do not bandage tightly or use with a heating pad, avoid contact with eyes or mucous membranes, do not apply to wounds or damaged skin.
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days if symptoms clear up and occur again within a few days, or if redness or irritation develops.
Otc - Pregnancy Or Breast Feeding
Ask a health-care professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Indications & Usage
Adults and children over 12 years: apply generously to the affected area, massage into painful area until thoroughly absorbed into the skin, repeat as necessary, but no more than 4 times daily. Children under 12 years or younger: ask a doctor.
Inactive Ingredient
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Blue 1, Copper PCA, Ethyhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Isopropyl Alcohol, Phenoxyethanol, Water.
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