Drug Facts: Active Ingredients
Menthol
Methal Salicylate
Eucalyptus Oil
Theraderm Pain Relieving Patch
FDA Label NDC 16903-168
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Manna Omni International Incorporated for the product Theraderm Pain Relieving Patch (NDC 16903-168). 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 drug facts: active ingredients, uses:, warnings: for external use only, keep out of the reach of children, directions:, inactive ingredients, indications and usage:, thera derm pain relieving patch, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses:
Temporarily relieves minor aches and pains of muscles and joints due to simple back ache, arthritis, strains, and sprains.
Warnings: For External Use Only
Use as directed
do not get into eyes or on mucous membranes
do not apply to wounds, damaged. or sensative skin
do not bangage tightly or cover with any type of wrap or cloth
do not use with a heating pad or apply external heat
do not use in combination with other external analgesic products
Stop use and ask a doctor if:
Condition worsens
excessive redness, burning,irritation, or discomfort of the skin developes
pain persists for more than seven days
symptoms clear up and occur again within a few days
Keep Out Of The Reach Of Children
If swallowed, get medical help and contact a poision center right away.
Directions:
Adults and children 12 years and over apply to affected area, change patch 2 to 3 times daily.
Children under 12 years ask a doctor before use.
How to apply:
Clean and dry affected area.
Cut open poutch and remove patch.
If desired, cut patch to size.
remove protective film from adhesive, apply directly onto site of pain, and secure ith adhesive strips.
Inactive Ingredients
Aloe extract, Zinc Oxide, Angelicae Sinensis RX, Cauda, Salviae Militorrhiza. CHuanxiong, Paeonea Rubra, Frankinsence, Myrrha, Notoginseng, Carthami Flos Persicae Sm, Angelica Pubescentis RX, Zingiberis RZ, Thymol.
Indications And Usage:
Thera Derm Pain relieving Patch is used for minor back aches, muscle aches, sprains, and strains.
Thera Derm Pain Relieving Patch
Thera Derm Patch (Theraderm Pain Relieving Patch New Ndc)
* Please review the disclaimer below.
