Otc - Active Ingredient
Active Ingredient:
Benzocaine - 5.0%
Myderm Bite And Sting Ointment
FDA Label NDC 53329-038
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries for the product Myderm Bite And Sting (NDC 53329-038). 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 - stop use, 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
Benzocaine - 10.0% ............Pain Relief
Indications & Usage
Temporary relief of pain and itching associated with insect bites
Warnings
For external use only
When using this product • avoid contact with the eye
Otc - Stop Use
Stop use and ask a doctor if • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Direction 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 a physician
Inactive Ingredient
Aloe Barbadensis Leaf Extract
Camphor
Chamomilla Recutita (Matricaria) Flower Extract
Diazolidinyl Urea
Disodium EDTA
Eugenia Caryophyllus (Clove) Flower Oil
Hydrocortisone
Inactive Ingredients:
Mentha Piperita (Peppermint) Oil
Menthol
Methylparaben
Olea Europaea (Olive) Fruit Oil
Papain
PEG-2 Stearate
PEG-2 Stearate SE
Polyethylene
Propylene Glycol
Propylparaben
SD Alcohol 40
Water
Package Label.Principal Display Panel
Myderm Bite Relief (Scan2021 12 14 131242)
* Please review the disclaimer below.
