Otc - Active Ingredient
Active Ingredients
Menthol 1.0% w/w
Aromalief Cozy Vanilla Pain Relief Cream Lotion
FDA Label NDC 72393-303
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marketites Llc for the product Aromalief Cozy Vanilla Pain Relief Cream (NDC 72393-303). 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, otc - ask doctor, otc - keep out of reach of children, directions, ohter information, 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
Use For temporary relief of pain
Warnings
Warnings
For external use only. Avoid contact with eyes.
Otc - Ask Doctor
Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days, or new symptoms occur.
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. If pregnant or breastfeeding, ask a health professional.
Directions
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
Ohter Information
Store in a cool dry place between 68° and 77°F and relative humidity not exceeding 65%.
Do not use if seal is broken, torn or missing.
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Water, Stearyl Alcohol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Myristate, Glyceryl Stearate, Menthyl Lactate, Glycerin, PEG 100 Stearate, Cannabis Sativa Seed Oil, Ulva lactuca Linnaeus, Fucaceae Fucus Vesiculosus, Sodium Hyaluronate, Helianthus Annuus (Sunflower) Seed Oil, Fragrance, Lavandula Angustifolia (Lavender) Flower Oil, Maltodextrin, Glucosamine Sulfate, Dimethyl Sulfone (MSM), L-Arginine, Glycol Stearate, Phenoxyethanol, Caprylyl Glycol
Questions
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