Thera Derm Roll On
FDA Label NDC 16903-171
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Manna Omni International Incorporated for the product Thera Derm Roll On (NDC 16903-171). 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 dosage & administration, indications & usage, warning: for external use only, keep out of the reach of children, active ingredients:, inactive ingredients:, otc - purpose, theraderm roll on, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
For the relief of minor aches and pains, muscles aches or sprains, and minor back or arthritis pain.
Warning: For External Use Only
Use only as directed. Avoid contact with the eyes and mucous membranes. Do not apply to wounds, damaged or very sensitive skin. Test on a small area before use. DO not use in combination with other analgesic products.DO not bandage tightly or cover with any type of wrap except clothing. If condition worsens, or persists for more than seven days, discontinue use and consult a physician.
Keep Out Of The Reach Of Children
If swallowed,get medical help or contact Poision Control right away.
Active Ingredients:
Menthol Natural
Methyl Salicilate
Peppermint oil
Menthol Crystal
Inactive Ingredients:
Aloe extract, Vitamin E Oil ,Lavender Flos,Angelicae Sinesis Rx, Cauda,Salviae,Miltiorrhiza, Chuanxiong, Paeoniae Rubra, Frakinsense, Mrryha, Carthami Flos, Persicae Sm, Cordalis Rz, Nototerygium, Incisum, and Angelica Pubescentis Rx.
Otc - Purpose
For the relief of minor aches and pains, related to strains and sprains and minor injury.
Theraderm Roll On
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