Label: FIRST AID TRIPLE ANTIBIOTIC WITH PAIN RELIEVER- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 68421-6500-0 - Packager: Cintas First Aid & Safety
- 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 September 15, 2010
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each gram)
- Purpose
- INDICATIONS & USAGE
- Warnings
- Do not use
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
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PRINCIPLE DISPLAY PANEL
SUPER
BIOTIC
WOUND OINTMENT#100210
FIRST AID
TRIPLE ANTIBIOTIC
WITH PAIN RELIEVER0.7g (1/41 oz.)
Mfd for FAD
First Aid Direct
Mason, OH 45040Active ingredients (in each gram)
Bacitracin zinc (400 units Bacitracin)
Neomycin sulfate (3.5 mg neomycin)
Polymyxin B sulfate (5000 units)
Lidocaine 40 mgPurpose
First Aid Antibiotic
First Aid Antibiotic
First Aid Antibiotic
AnestheticUses First aid to help prevent infection and provide temporary relief in minor cuts, scrapes, and burns
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INGREDIENTS AND APPEARANCE
FIRST AID TRIPLE ANTIBIOTIC WITH PAIN RELIEVER
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68421-6500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength bacitracin zinc (UNII: 89Y4M234ES) (bacitracin zinc - UNII:89Y4M234ES) bacitracin zinc 400 [iU] in 1 g neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297) neomycin sulfate 3.5 mg in 1 g polymyxin b sulfate (UNII: 19371312D4) (polymyxin b - UNII:J2VZ07J96K) polymyxin b sulfate 5000 [iU] in 1 g lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987) lidocaine 40 mg in 1 g Inactive Ingredients Ingredient Name Strength petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68421-6500-0 0.7 g in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 03/30/2007 Labeler - Cintas First Aid & Safety (056481716) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE