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Drug Facts
Triple Antibiotic Ointment
FDA Label NDC 87236-016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aldermed Inc. for the product Triple Antibiotic (NDC 87236-016). 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 other, active ingredients, purpose, uses, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Bacitracin Zinc (400 units in each gram)
Neomycin Sulfate 5mg (equivalent to 3.5mg Neomycin per gram)
Polymyxin B Sulfate (5000 units per gram)
Pramoxine HCl USP (10mg in each gram)
Purpose
First Aid Antibiotics
External analgesic
Uses
First Aid to help prevent infection in minor cuts, scrapes and burns
Warnings
For external use only.
Do Not Use
Do not use
- If you are allergic to any of the ingredients
- In the eyes
- over large areas of the body
Otc - When Using
Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns
Otc - Stop Use
Stop use and ask a doctor if
- you need to use longer thab 1 week
- the condition persists or gets worse
- rash or other allergic reaction develops
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 (1-800-222-1222)
Directions
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
Other Information
- To open, unscrew cap, pull tab to remove foil seal.
- Store at room temperatue 20° to 25°C (68° to 77° F)
- See carton ot tube crimp for Lot Number and Expiry Date
Inactive Ingredients
White Petrolatum
Questions?
Contact 1-800-707-4621
Manufactured in India by:
Gopaldas Visram & Company Limited.
Plot No. A327, T.T.C. Indl. Area, M.L.D.C.
Mahape, Navi Mumbai - 400710.
Mfg. Lic. No.: KD/503
* Please review the disclaimer below.
