Active Ingredients
Bacitracin 500 units
Neomycin 3.5.mg
Polymyxin B 10,000 units
Procomycin
FDA Label NDC 33261-788
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aidarex Pharmaceuticals Llc for the product Procomycin (NDC 33261-788). 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, active ingredient, uses, warnings, do not use, consult a doctor, stop use and consult a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antibiotic
Local Anesthetic
Active Ingredient
Lidocaine Hydrochloride 4%
Uses
- First aid to help prevent the infection in minor cuts, scrapes and burns
- For the temporary relief of pain or itching.
Warnings
For external use only.
Do Not Use
- in the eyes
- over large areas of the body
- if allergic to any of the ingredients
- longer than 1 week unless directed by a doctor.
Consult A Doctor
- if under 2 years of age
- in case of deep cuts or puncture wounds, animal or human bites, or serious burns
- if pregnant or breast feeding.
Stop Use And Consult A Doctor
- if the condition persists or worsens
- if symptoms persist for more than 7 days or clear up and occur again within a few days
- if a rash or other allergic reaction develops.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions For Use
- Clean the affected area
- apply a small amount of this product (an amount equal to the surface area of the tip of the finger) on the area 3 times daily.
- may be covered with a sterile bandage
- store at controlled room temperature 15°-30° (59°-86°).
Inactive Ingredients
acrylates/dimethicone coploymer, allantoin, aloe barbadensis (aloe vera) leaf juice, arachidyl alcohol, arachidyl glucoside, arnica montana flower extract, ascorbic acid (vitamin C), behenyl alcohol, beta-glucan, benzalkonium chloride, beta-glucan, butyrospermum parkii (shea) butter, C 12-15 alkyl benzoate, caprylic/capric triglyceride, cetearyl alcohol, cetearyl glucoside, cyclopentasiloxane, dimethicone, dipalmitoyl hydroxyproline, glycerin, glycine soja (soybean) oil, helianthus annuus (sunflower) seed oil, hydrolyzed mytilus edulis byssus, methylparaben, panthenol, persea gratissima (avocado) oil, phenoxyethanol, polyglyceryl-6 distearate, propylparaben, sclerotium gum, tocopherol, water (aqua)
Manufactured in the USA for:
Physician's Science and Nature, Inc.
220 Newport Center Drive, 11-634,
Newport Beach, CA 92660
Repackaged By:
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880
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