Active Ingerdients
Witch Hazel Distillate 42.50%
Lidocaine HCl 5.00%
Penylephrine HCI 0.25%
Myderm Spray
FDA Label NDC 72667-081
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Inspec Solution Llc. for the product Myderm (NDC 72667-081). 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 active ingerdients, purpose, uses, warning, when using this product, ask a doctor or pharmacist, stop use and ask doctor, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Witch Hazel Distillate .......................Anesthetic
Lidocaine HCl 5.00% .......................Anesthetic
Penylephrine HCI 0.25% .................Vasoconstrictor
Uses
Uses: Temporary shrinks hemorrhoidal tissue •Temporarily reduces swelling associated with irritated anorectal areas.
Warning
For external use only
When Using This Product
When using this product • avoid spraying in eye• content under pressure •do not puncture or incinerate •do not store at temperature above 120° F •do not exceed recommended daily dosage unless directed by doctor •do not put this product into rectum by using fingers or any mechanical device or applicator
Ask A Doctor Or Pharmacist
Ask a doctor or pharmacist before use if you have • heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of prostate gland •are presently taking a prescription drug or high blood pressure or depression.
Stop Use And Ask Doctor
Stop use and ask doctor if • condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use
Keep Out Of Reach Of Children
Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center immediately
Directions
Directions • For adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily •Children under 2 years of age: consult physician.
Question?
Question? 1-855-myderm1
Inactive Ingredient
Alcohol
Aloe Barbadensis Leaf
Benzophenone-4
Disodium EDTA
Tocopheryl Acetate
Ethylhexylglycrin
Phenoxyethanol
Polysorbate-20
Propylene Glycol
Sodium Citrate
Water
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