OTC - ACTIVE INGREDIENT SECTION
Benzocaine 20%, Resorcinol 3%
Benzocaine 20%, Resorcinol 3%
Topical analgesic
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.
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.
If swallowed, get medical help or contact a Poison Control Center right away.
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.
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.
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78589-233-02 | Mirakel Pain and Itch Relief | 95 g in 1 TUBE | CREAM | 95 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 78589-233 | 78589-233-02 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mirakel Pain and Itch Relief | BENZOCAINE 20%, RESORCINOL 3% | Sanvio, Inc. | ed34d728-0275-e209-e053-2995a90a93ff | 2024-12-20 | Warnings | 78589-233-02 78589-233 78589023302 29b77abb-b9cb-c24d-e063-6394a90a8110 ed34d728-0275-e209-e053-2995a90a93ff |
Adverse event summaries are temporarily unavailable. Other product information remains available.