Otc - Active Ingredient
Lidocaine HCl 4%
Mirakel Pain Relief Roll-on Gel
FDA Label NDC 78589-257
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sanvio, Inc. for the product Mirakel Pain Relief Roll-on (NDC 78589-257). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical anesthetic
Indications & Usage
Temporarily relieves minor pain.
Warnings
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
- 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
Stop use and ask a doctor if
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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
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
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