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| Product NDC Code | 78589-257 | ||||
|---|---|---|---|---|---|
| Drug Name | Mirakel pain relief roll-on |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1010077 | ||||
| Application Number | M017 | ||||
| Labeler Name | Sanvio, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Lidocaine HCl 4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Clean affected area before applying product. Adults and children 12 years and older : apply to the affected area not more than 3 to 4 times daily. Children under 12 years old: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Alcohol Denat., Glyceryl Stearate, Cetearyl Alcohol, Dimethicone, Aminomethyl Propanol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Salix Alba (Willow) Bark Extract, Curcuma Longa (Turmeric) Root Extract, Mentha Piperita (Peppermint) Leaf Extract, Eucalyptus Globulus Leaf Oil, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Ceteth-20 Phosphate, Dicetyl Phosphate, Disodium EDTA, Ethylhexylglycerin, Steareth-21, Methylparaben
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Temporarily relieves minor pain.
Purpose
Information about the drug product’s indications for use.Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Mirakel Pain Relief Roll-On Lidocaine HCl C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER CAPRYLYL TRISILOXANE METHYLPARABEN MENTHA PIPERITA LEAF ALCOHOL CETOSTEARYL ALCOHOL WATER GLYCERYL MONOSTEARATE AMINOMETHYLPROPANOL EUCALYPTUS OIL ALOE VERA LEAF LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS STEARETH-21 GLYCERIN ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) CETETH-20 PHOSPHATE DIHEXADECYL PHOSPHATE EDETATE DISODIUM ETHYLHEXYLGLYCERIN DIMETHICONE 200 ARNICA MONTANA FLOWER SALIX ALBA BARK TURMERIC
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.If swallowed, get medical help or contact a Poison Control Center right away.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.For external use only. Flammable-- keep away from fire or flame. Do not use if you have an allergic reaction to lidocaine or other local anesthetics on large areas of the body or on cut, irritated, blistered, or swollen skin on puncture wounds for more than one week without consulting a doctor Stop use and ask a doctor if condition worsens severe burning sensation, redness, rash, or irritation develops symptoms persist for more than 7 days or clear p and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API