Mirakel Max Strength Pain And Itch Relief, Benzocaine 20%, Resorcinol 3%

Mirakel Max Strength Pain And Itch Relief, Benzocaine 20%, Resorcinol 3%
SPL v2
SPL
SPL Set ID ed34d728-0275-e209-e053-2995a90a93ff
Route
TOPICAL
Published
Effective Date 2022-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g) Resorcinol (3 g)
Inactive Ingredients
Isopropyl Myristate Vitamin A Palmitate Glyceryl Monostearate Aloe Vera Leaf Cetyl Alcohol Water Glycerin Calendula Officinalis Flower Chamomile .alpha.-tocopherol Acetate Basil Methylparaben Carbomer 934 Propylene Glycol Peg-100 Stearate Feverfew Azadirachta Indica Leaf Edetate Disodium Mineral Oil Cholecalciferol Peppermint Oil Corn Oil Trolamine Lanolin Sodium Sulfite

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-11

Description

Benzocaine 20%, Resorcinol 3%


Medication Information

Warnings and Precautions

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.

Indications and 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.

Dosage and 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.

Description

Benzocaine 20%, Resorcinol 3%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

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.

Section 51945-4

Section 55105-1



Topical analgesic

Section 55106-9

Benzocaine 20%, Resorcinol 3%


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Topical analgesic

Section 55106-9 (55106-9)

Benzocaine 20%, Resorcinol 3%


Advanced Ingredient Data


Raw Label Data

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