The following Structured Product Label (SPL) was submitted to the FDA by Inspec Solutions for the product Myderm Medical New Soothing Hemorrhoidal (NDC 72667-287). 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 ingredients purpose, uses, directions, warnings for external use only., keep out of reach of children., inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Witch Hazel Extract 50.00%.....................................................Anesthetic
Lidocaine HCl 5.00%................................................................Anesthetic
Phenylephrine Hydrochloride 0.25%................................Vasoconstrictor
Temporarily shrinks hemorrhoidal tissue. • Temporarily reduces
swelling associated with irritation • Helps protect irritated anorectal areas.
• Adults and children 2 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.
When using this product• avoid spraying in eyes. • contents 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 before use ifyou have • heart disease,
high blood pressure, thyroid disease, diabetes, difficulty in urination due
to enlargement of prostate gland. • are presently taking a prescription
drug for high blood pressure or depression.
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 breastfeeding, ask a healthcare professional before use.
If swallowed, get medical help or contact a Poison Control Center immediately.
Alcohol, Aloe Barbadensis Leaf,
Benzophenone-4, Disodium EDTA, Tocopheryl Acetate, Ethylhexylglycrin,
Phenoxyethanol, Polysorbate-20, Propylene Glycol,
Sodium Citrate, Water.
* Please review the disclaimer below.
