Label: MIRAKEL PAIN AND ITCH RELIEF- benzocaine 20%, resorcinol 3% cream
- NDC Code(s): 78589-233-02
- Packager: Sanvio, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 11, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- DOSAGE & ADMINISTRATION
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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
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INGREDIENTS AND APPEARANCE
MIRAKEL PAIN AND ITCH RELIEF
benzocaine 20%, resorcinol 3% creamProduct 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)
