Label: REPARA TRIPLE ANTIBIOTIC- bacitracin, neomycin and polymyxin b ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 68345-820-22, 68345-820-26 - Packager: PSS WORLD MEDICAL, INC.
- Category: HUMAN OTC DRUG LABEL
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 June 19, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Igredients:
- Purpose:
- Inactive Ingredients:
- KEEP OUT OF REACH OF CHILDREN
- Uses:
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Warnings:
FOR EXTERNAL USE ONLY.
Do not use
• in the eyes or apply over large areas of the body
• if you are allergic to any of the ingredients
Ask a doctor before use if you have
• deep or puncture wounds, animal bites or serious burns
Stop use and ask a doctor if
• the condition worsen
• symptons last more than 7 days or clear up and occur again within a few days
- Directions:
- Comments or Questions?
- Storage Information
- Package Label
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INGREDIENTS AND APPEARANCE
REPARA TRIPLE ANTIBIOTIC
bacitracin, neomycin and polymyxin b ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68345-820 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 SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (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:68345-820-22 12 in 1 CASE 1 144 in 1 BOX 1 0.9 g in 1 POUCH 2 NDC:68345-820-26 12 in 1 CASE 2 12 in 1 BOX 2 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) Registrant - Zhejiang Medicare Pharmaceutical Co., Ltd. (421293835) Establishment Name Address ID/FEI Business Operations Zhejiang Medicare Pharmaceutical Co., Ltd. 421293835 manufacture(68345-820)