Inactive Ingredient
Inactive Ingredients carbomer, laureth-23, methylparaben, mineral oil, propylene glycol, propylparaben, stearamidoethyl diethylamine, stearic acid, stearyl alcohol, triethanomoline, water
Theraplus Ointment
FDA Label NDC 55621-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Jingwei Pharmaceutical Co., Ltd. for the product Theraplus (NDC 55621-004). 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 inactive ingredient, otc - active ingredient, warnings, otc - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient
Menthol 10%
Menthol salicylate 15%
Warnings
Warnings
For external use only.
Do not use
-on wounds or damaged skin -with a heating pad - on a child under 12 years of age with arthritis-like condition
When using this product
-avoid contact with eyes and mucous membranes -do not bandage tightly
Otc - Purpose
Purpose
Topical analgesic
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
Indications & Usage
Uses temporarily relieves minor aches and pains of muscles and joints associated with:
-simple backache -arthritis -bruises -strains -sprains
Dosage & Administration
Directions
-adults and children 12 years of age and older: apply to all affected area not more than 3 to 4 times daily
-children under 12 years of age: ask a doctor
Package Label.Principal Display Panel
Copy Of Label (Zhejiang Muscle)
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