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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mirakel Max Strength Pain and Itch Relief, 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.

Carton

MIRAKEL PAIN AND ITCH RELIEF 
benzocaine 20%, resorcinol 3% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78589-233
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78589-233-0295 g in 1 TUBE; Type 0: Not a Combination Product07/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/11/2022
Labeler - Sanvio, Inc. (100812165)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(78589-233)

Revised: 11/2022
Document Id: ed34d728-0276-e209-e053-2995a90a93ff
Set id: ed34d728-0275-e209-e053-2995a90a93ff
Version: 1
Effective Time: 20221111
 
Sanvio, Inc.