DRUG FACTS

DRUG FACTS

Drug Labeling and Warnings

Drug Details

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ULTRA SEAL TRIPLE ANTIBIOTIC  - neomycin, polymixin, bacitracin ointment 
Ultra Seal Corporation

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.

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DRUG FACTS

Actve Ingredients: In each gram-Neomycin Sulfate-5 mg (equivalent to 3.5 mg Neomycin), Polymixin B Sulfate-5000 I.U., Bacitracin Zinc-400 I.U.

PURPOSE: FIRST AID ANTIBIOTIC

 FIRST AID TO HELP PREVENT INFECTION IN MINOR CUTS, BURNS, SCRAPES

FOR EXTERNAL USE ONLY.  DO NOT USE IN THE EYES.  DO NOT USE IF YOU ARE ALLERGIC TO ANY OF THE INGREDIENTS DUE TO THE POSSIBILITY OF ANAPHYLACTIC SHOCK.

STOP USE AND ASK A DOCTOR BEFORE USE IN CASES OF DEEP PUNCTURE WOUNDS, ANIMAL BITES, SERIOUS BURNS; IF THE CONDITION PERSISTS OR GETS WORSE;IF A RASH OR OTHER ALLERGIC REACTION DEVELOPS

IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY




KEEP OUT OF THE REACH OF CHILDREN

 CLEAN THE AFFECTED AREA.  APPLY A SMALL AMOUNT OF PRODUCT (AN AMOUNT EQUAL TO THE SURFACE AREA OF THE TIP OF A FINGER) ON THE AREA 1-3 TIMES DAILY.

MAY BE COVERED WITH A STERILE BANDAGE

INACTIVE INGREDIENT: WHITE PETROLATUM

MM1USC Triple tube carton

ULTRA SEAL TRIPLE ANTIBIOTIC  
neomycin, polymixin, bacitracin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42213-360
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [iU]  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42213-360-80144 in 1 BOX
1NDC: 42213-360-090.9 g in 1 PACKET
2NDC: 42213-360-281 in 1 CARTON
228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B04/12/2011
Labeler - Ultra Seal Corporation (085752004)
Registrant - ULTRAtab Laboratories, Inc. (151051757)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture

Revised: 4/2011
 
Ultra Seal Corporation


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