Inactive Ingredients Section
Inactive Ingredients: Natural Citrus Fiber,
Dimethicone, Isopropyl Alcohol, Jojoba Oil,
Phenoxyethanol, Simethicone, Water
Pain Relief Roll On
FDA Label NDC 84890-282
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fit Life Health, Llc for the product Pain Relief Roll On (NDC 84890-282). 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 ingredients section, active ingredient section see capsaicinlabel.jpg, dosage and administration, warnings, indications & usage, otc - keep out of reach of children, purpose section, primary label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient Section See Capsaicinlabel.Jpg
Menthol 6%........................................ Topical Analgesic
Camphor 5%....................................... Topical Analgesic
Capsaicin 0.025%............................... Topical Analgesic
Active Ingredients (Active Ingredients)
Dosage And Administration
Directions (Directions)
Directions: • Adults and children over 12 years old:
apply to affected area – do not apply more than 4 times
daily • Children 12 years or younger: Consult a doctor
Warnings
Warning And Precautions
Warnings And Precautions (Warnings And Precautions)
Indications & Usage
Uses: For the temporary relief of aches and pains of
muscles and joints associated with arthritis,
backaches, strains or sprains
Usage (Usage)
Otc - Keep Out Of Reach Of Children
Keep Out Of Reach Of Children
Keep out of reach of children: If ingested, get
medical help or contact Poison Control Center
immediately: 1-800-222-1222
Purpose Section
For the temporary relief of aches and pains of
muscles and joints associated with arthritis,
backaches, strains or sprains
Primary Label
Primary Label
Temporary Relief of
Primary_label (Primary Label)
aches and pains
3 FL OZ (88 ML)
* Please review the disclaimer below.
