Otc - Active Ingredient
Menthol 8%
Owell Naturals Pain Relief Cream
FDA Label NDC 83570-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Owell Naturals Brand Llc for the product Owell Naturals Pain Relief Cream (NDC 83570-500). 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, indications & usage, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, 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
Topical Analgesic
Indications & Usage
Arthritis Pain, Sore Joints and Muscles, Sore Throat, Sinus Trouble, Restless Leg Syndrome
Warnings
Warnings
For External Use Only.
Allergy Alert: If prone to allergic reaction from aspirin or salicylate, consult your doctor before using.
Do Not Use
■ on wounds or damaged skin ■ with a heating pad
■ on a child under 12 years of age with arthritis-like conditions
Ask a doctor before use if you have redness over the affected area.
When Using This Product ■ avoid contact with eyes or other sensitive areas ■ do not bandage tightly
Stop use and ask a doctor if
■ condition worsens or symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ excessive skin irritation occurs
Keep out of reach of children to avoid accidental ingestion. If swal- lowed, get medical help or contact
a Poison Control Center immediately.
Dosage & Administration
Directions ■ use only as directed
■ adults and children 12 years of age and older: apply to affected area
■ children under 12 years of age: ask a doctor
Inactive Ingredient
Inactive ingredients Water, Carthamus tinctorius (Hybrid Safflower) Seed Oil, Helianthus annuus (Sunflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe barbadensis (Aloe Vera) Leaf Juice, Beeswax, Hydro- genated Castor Oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus globulus Leaf Oil, Chlorphenesin, Cinnamomum camphora Bark Oil, Abies sibirica Needle Oil, Methyl Salicylate, Sodium Chloride
Otc - Keep Out Of Reach Of Children
Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.
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