Label: MIRAKEL- benzocine 10%, resorcinol 1.5% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 78589-100-01, 78589-100-02 - 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 July 15, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Uses
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Warnings
Warnings
For external use only
When using this product ■ avoid contact with eyes ■ do not apply
over large areas of the bodyStop use and ask a doctor if ■ condition worsens or symptoms persist
for more than 7 days, or clear up and occur again within a few daysKeep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center immediately. - Keep Out Of Reach of Children
- Directions
- Other Information
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Inactive Ingredients
Inactive ingredients aloe barbadensis (aloe vera) leaf extract,
butylated hydroxytoluene, carbomer, cetyl
alcohol, cholecalciferol, edetate disodium,
glyceryl monostearate, isopropyl palmitate,
maltodextrin, mentha piperita (peppermint) oil,
methylparaben, mineral oil, PEG-40 hydrogenated
castor oil, PEG-100 stearate,petrolatum,
propylene glycol, propyl-paraben, purified
water, retinyl palmitate, sodium lauryl sulfate,
thymus vulgaris (thyme) flower leaf oil, tocopheryl
acetate triethanolamine, xanthan gum. - Questions
- Purpose
- Pricipal Display Panel
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INGREDIENTS AND APPEARANCE
MIRAKEL
benzocine 10%, resorcinol 1.5% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78589-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 0.1 g in 1 g RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL 0.015 g in 1 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) 0.03 g in 1 g Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78589-100-01 1 g in 1 TUBE; Type 0: Not a Combination Product 06/01/2020 2 NDC:78589-100-02 1 g in 1 BOX; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/2020 Labeler - Sanvio, Inc. (100812165) Registrant - Sanvio, Inc. (100812165) Establishment Name Address ID/FEI Business Operations Sanvio, Inc. 100812165 manufacture(78589-100)