MIRAKEL PAIN AND ITCH RELIEF- benzocaine 20%, resorcinol 3% cream

Mirakel Pain and Itch Relief by

Drug Labeling and Warnings

Mirakel Pain and Itch Relief by is a Otc medication manufactured, distributed, or labeled by Sanvio, Inc., Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine 20%, Resorcinol 3%

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.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIRAKEL PAIN AND ITCH RELIEF 
benzocaine 20%, resorcinol 3% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78589-233
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BASIL (UNII: 2U0KZP0FDW)
METHYLPARABEN (UNII: A2I8C7HI9T)
CARBOMER 934 (UNII: Z135WT9208)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-100 STEARATE (UNII: YD01N1999R)
FEVERFEW (UNII: Z64FK7P217)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
PEPPERMINT OIL (UNII: AV092KU4JH)
CORN OIL (UNII: 8470G57WFM)
TROLAMINE (UNII: 9O3K93S3TK)
LANOLIN (UNII: 7EV65EAW6H)
SODIUM SULFITE (UNII: VTK01UQK3G)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78589-233-02	95 g in 1 TUBE; Type 0: Not a Combination Product	07/11/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/11/2022

Labeler - Sanvio, Inc. (100812165)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(78589-233)