Otc - Active Ingredient
Active ingredient Purpose
Menthol (5.0%) Topical Analgesic
Methyl Salicylicate (10%) Topical Analgesic
Te-fu Recovery Massage Lotion
FDA Label NDC 44717-539
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wasatch Product Development for the product Te-fu Recovery Massage (NDC 44717-539). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, 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 - Purpose
Uses
Provides warming, penetrating pain relief for sore muscles and joints
May also provide temporary relief of minor aches and pains associated with backache, strains and bruises
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician.
Warnings
Warnings
For external use only.
Avoid contact with eyes
Do not bandage tightly
Dosage & Administration
Directions
Adults and children 2 year of age and older apply to affected area not more than 3 to 4 times per day
Children under 2yrs of age consult a physician.
Inactive Ingredient
Inactive ingredients: Water, Cinnamomium Camphora (Camphor) Bark Oil, Stearyl Alcohol, C13-15 Alkane, Glycerin, Caprylic/capric Triglyceride, Pentylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Eucalyptus Globulus Leaf Oil, Prunus Amygdalus Dulcis( sweet almond) Oil, Microcrystalline Cellulose, Mentha Piperita (peppermint) Oil, Behenyl Alcohol, Stearyl Phosphate, Eugenia Caryophyllus (Clove) Leaf Oil, Hydroxyacetophenone, Zingiber Officinale (ginger) Root Oil, Arnica Montana Flower Extract, Benzyl Alcohol, Cellulose Gum, Cyamopsis Tetragonoloba (Guar) Gum, Xanthan Gum, Sodium Phytate.
Package Label.Principal Display Panel
Tei-Fu
Recovery Massage Lotion
Penetrating Muscle and Joint Relief
4fl. oz. ( 118 mL)
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