The following Structured Product Label (SPL) was submitted to the FDA by Manna Omni International Incorporated for the product Theraderm (NDC 16903-169). 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 warning: for external use only., keep out of the reach of children., indications & usage, dosage:, other ingredients:, active ingredients:, purpose:, use:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Use only as directed. Avoid contact with eyes or mucus menmbranes. Do not apply to worn, damaged, or very sensitive skin. Test on a small area before use. Do not Use in combination with other external analgesic products. Do not bandage tightly, or cover with any type of wrap, except clothing. If condition worsens , or persists for more than 7 days, discontinue use and consult a physcian.
If swallowed, get medical attention or contact poision control Immediately.
DIrections: Spray a small amount onto affected area. Repeat 3-4 times daily.
Spray small amount onto affected area every 6 hours no more than 4 times a day.
Aloe Extract, am pelopsis radix extract, bletilla tuber extract, Carthmiflos extract,cimicifugae rhizome extract,echinopsis radix extract, glycerin, glycerrhizae radix extract,kaolin,methyl saliciate, myrrha extract, frankincense extract,Poly Acrylic acid,polysorbate 80,polyvinyl alcohol,propyl glycol,propyl paraben, purified water,rhei rhizome extract,titanium oxide,triethanolamine,glucosamine,and MSM.
Methyl Salcylate, Menthol Natural (From Peppermint oil), and Menthol Crystal Solution.
For the temporary relief of minor arthritis pain, simple back ache, muscle sprains, and muscle strains.
For the temporary relief of minor muscle pain, simple back aches, muscle strain or sprain.
* Please review the disclaimer below.
