Indications & Usage
Directions: FOR TOPICAL USE ONLY.
Melissa
FDA Label NDC 48951-7203
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Uriel Pharmacy Inc. for the product Melissa (NDC 48951-7203). 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 indications & usage, dosage & administration, otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, warnings, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Apply to skin as needed. Under age 2: Consult a doctor.
Otc - Active Ingredient
Active Ingredients: 100 gm contains: 35 gm Melissa (Lemon balm) 1X; Aconitum (Monkshood) 30X, Atropa belladonna (Nightshade) 30X, Rhus (Sumac) 30X
Inactive Ingredient
Inactive Ingredients: Spring water, Stearic acid, Isopropyl myristate, Lavender oil, Cetyl alcohol, Polyoxyl 40 stearate, Stearyl alcohol, Xanthan gum, Sorbic acid, Tea tree oil, Frankincense oil, Grapefruit seed extract, Myrrh oil
"prepared using rhythmical processes"
Otc - Purpose
Use: Temporary relief of cold sores.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Warnings
Warnings: FOR EXTERNAL USE ONLY.
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.
Otc - Questions
Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
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