{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2026-06-03",
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{
"spl_product_data_elements": [
"SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF polymyxin B sulfate, bacitracin zinc, neomycin sulfate, and pramoxine hydrochloride PETROLATUM BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B PRAMOXINE HYDROCHLORIDE PRAMOXINE"
],
"spl_unclassified_section": [
"Drug Facts",
"Distributed by McKesson One Post Street San Francisco, CA 94104"
],
"active_ingredient": [
"Active ingredients (in each gram) Purposes Bacitracin 500 units First aid antibiotic Neomycin 3.5 mg First aid antibiotic Polymyxin B 10,000 units First aid antibiotic Pramoxine HCl 10 mg Topical pain reliever"
],
"active_ingredient_table": [
"| Active ingredients (in each gram) | Purposes |
|---|
| Bacitracin 500 units | First aid antibiotic |
| Neomycin 3.5 mg | First aid antibiotic |
| Polymyxin B 10,000 units | First aid antibiotic |
| Pramoxine HCl 10 mg | Topical pain reliever |
"
],
"purpose": [
"Active ingredients (in each gram) Purposes Bacitracin 500 units First aid antibiotic Neomycin 3.5 mg First aid antibiotic Polymyxin B 10,000 units First aid antibiotic Pramoxine HCl 10 mg Topical pain reliever"
],
"purpose_table": [
"| Active ingredients (in each gram) | Purposes |
|---|
| Bacitracin 500 units | First aid antibiotic |
| Neomycin 3.5 mg | First aid antibiotic |
| Polymyxin B 10,000 units | First aid antibiotic |
| Pramoxine HCl 10 mg | Topical pain reliever |
"
],
"indications_and_usage": [
"Uses first aid to help prevent infection and for temporary relief of pain or discomfort in minor: cuts scrapes burns"
],
"warnings": [
"Warnings For external use only Do not use if you are allergic to any of the ingredients Ask a doctor before use if you have deep or puncture wounds animal bites serious burns When using this product do not use in the eyes do not apply over large areas of the body Stop use and ask a doctor if you need to use for more than 1 week condition persists or gets worse symptoms persist for more than 1 week or clear up and occur again within a few days 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"
],
"do_not_use": [
"Do not use if you are allergic to any of the ingredients"
],
"ask_doctor": [
"Ask a doctor before use if you have deep or puncture wounds animal bites serious burns"
],
"when_using": [
"When using this product do not use in the eyes do not apply over large areas of the body"
],
"stop_use": [
"Stop use and ask a doctor if you need to use for more than 1 week condition persists or gets worse symptoms persist for more than 1 week or clear up and occur again within a few days rash or other allergic reaction develops"
],
"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_and_administration": [
"Directions unscrew cap and pull tab to remove foil seal adults and children 2 years of age and older: clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor"
],
"storage_and_handling": [
"Other information store at controlled room temperature 15°-30°C (59°-86°F) see carton or tube crimp for lot number and expiration date"
],
"inactive_ingredient": [
"Inactive ingredient white petrolatum"
],
"how_supplied": [
"HOW SUPPLIED Product: 50090-6172 NDC: 50090-6172-0 28.4 g in a TUBE / 36 in a CASE"
],
"package_label_principal_display_panel": [
"polymyxin B sulfate, bacitracin zinc, neomycin sulfate, and pramoxine hydrochloride Label Image"
],
"set_id": "01131ba6-6d5b-4710-bec3-ba1769c08c79",
"id": "8ccae7c4-e443-4cec-a31d-764334293b65",
"effective_time": "20241022",
"version": "2",
"openfda": {
"application_number": [
"M004"
],
"brand_name": [
"SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF"
],
"generic_name": [
"POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE"
],
"manufacturer_name": [
"A-S Medication Solutions"
],
"product_ndc": [
"50090-6172"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"TOPICAL"
],
"substance_name": [
"BACITRACIN ZINC",
"NEOMYCIN SULFATE",
"POLYMYXIN B SULFATE",
"PRAMOXINE HYDROCHLORIDE"
],
"rxcui": [
"1359350"
],
"spl_id": [
"8ccae7c4-e443-4cec-a31d-764334293b65"
],
"spl_set_id": [
"01131ba6-6d5b-4710-bec3-ba1769c08c79"
],
"package_ndc": [
"50090-6172-0"
],
"original_packager_product_ndc": [
"49348-600"
],
"unii": [
"89Y4M234ES",
"057Y626693",
"19371312D4",
"88AYB867L5"
]
}
}
]
}