The following Structured Product Label (SPL) was submitted to the FDA by Sanvio, Inc. for the product Mirakel (NDC 78589-100). 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 active ingredients, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients Purpose
Benzocaine 10% .........................................................External Analgesic
Resorcinol 1.50%........................................................External Analgesic
Uses temporary relief of pain, itching and discomfort associated with:
■ rashes
■ minor cuts
■ minor burns
■ minor skin irritations
■ insect bites
Uses (Uses)
Warning (Warnings)
Warnings
For external use only
When using this product ■ avoid contact with eyes ■ do not apply
over large areas of the body
Stop use and ask a doctor if ■ condition worsens or symptoms persist
for more than 7 days, or clear up and occur again within a few days
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center immediately.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center immediately.
Directions (Directions)
Directions
■ adults and children 12 years and older: apply small amount to
affected area not more than 3-4 times a day.
■ children under 12 years of age: consult a doctor
Other Information ■ store at 20-25°C (68-77°F)
■ skin is more sensitive to sunlight when using this product.
■ keep tightly closed after use.
Inactive ingredients aloe barbadensis (aloe vera) leaf extract,
butylated hydroxytoluene, carbomer, cetyl
alcohol, cholecalciferol, edetate disodium,
glyceryl monostearate, isopropyl palmitate,
maltodextrin, mentha piperita (peppermint) oil,
methylparaben, mineral oil, PEG-40 hydrogenated
castor oil, PEG-100 stearate,petrolatum,
propylene glycol, propyl-paraben, purified
water, retinyl palmitate, sodium lauryl sulfate,
thymus vulgaris (thyme) flower leaf oil, tocopheryl
acetate triethanolamine, xanthan gum.
Questions (Questions)
Questions? Call 1-888-855-5681
Purpose (Purpose)
Active ingredients Purpose
Benzocaine 10% .........................................................External Analgesic
Resorcinol 1.50%........................................................External Analgesic
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