Otc - Active Ingredient
Benzocaine 20%, Resorcinol 3%
Mirakel Pain And Itch Relief Cream
FDA Label NDC 78589-233
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sanvio, Inc. for the product Mirakel Pain And Itch Relief (NDC 78589-233). 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 - keep out of reach of children, 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
Topical analgesic
Indications & Usage
For the temporary relief of minor aches and pain associated with minor burns, minor skin irritations, minor cuts, insect bites or stings, scrapes, and sunburns.
Warnings
For external use only. Do not use over large areas of the body. Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics. When using this product avoid contact with eyes, use only as directed. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days, symptoms clear up and occur again within a few days, itching, rash or irritation develops.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.
Inactive Ingredient
Water, mineral oil, cetyl alcohol, propylene glycol, glyceryl stearate, PEG-100 stearate, isopropyl palmitate, ocimum basilicum (basil) leaf extract, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, chrysanthemum parthenium (feverfew) extract, melia azadirachta leaf extract, glycerin, tocopheryl acetate, aloe barbadensis leaf extract, retinyl palmitate, cholecalciferol, mentha piperita (peppermint) oil, zea mays (corn) oil, isopropyl myristate, carbomer, triethanolamine, lanolin, disodium EDTA, sodium sulfite, methylparaben.
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