Label: SELECT MEDICAL PRODUCTS TRIPLE ANTIBIOTIC- bacitracin, neomycin and polymyxin b ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 68345-814-22, 68345-814-24, 68345-814-26 - Packager: PSS WORLD MEDICAL, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 25, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Warnings:
FOR EXTERNAL USE ONLY. Do not use in the eyes or apply over large areas of the body.
• In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.
Stop use and consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops.
Do not use if you are allergic to any of the ingredients.
• Do not use longer than 1 week unless directed by a doctor.
• KEEP OUT OF REACH OF CHILDREN.
In case of accidental ingestion, contact a Poison Control Center right away.
- Directions:
- Inactive ingredients:
- Comments or Questions about Select Medical Products? 800-777-4908
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INGREDIENTS AND APPEARANCE
SELECT MEDICAL PRODUCTS TRIPLE ANTIBIOTIC
bacitracin, neomycin and polymyxin b ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68345-814 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g POLYMYXIN B (UNII: J2VZ07J96K) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68345-814-22 0.9 g in 1 POUCH 2 NDC:68345-814-24 1 in 1 BOX 2 14 g in 1 TUBE 3 NDC:68345-814-26 1 in 1 BOX 3 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 12/01/2007 Labeler - PSS WORLD MEDICAL, INC. (101822682)
