TRIPLE ANTIBIOTIC EXTRA STRENGTH- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment 
Personal Care Products, Inc.

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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Active ingredients

Drug Facts

Bacitracin zinc 400 Units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 5,000 Units


Purpose

First aid antibiotic

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

First aid to help prevent infection in minor

Warnings

For external use only

Allergy Alert: do not use if you are allergic to any of the ingredients

Do not use

Directions

Other information

Inactive ingredients

methylparaben, mineral oil, ozocerite, petrolatum, propanediol, propylparaben


Product Label

DRUGSTORE-Rx

SMART WELLNESS

Extra Strength

Triple Antibiotic Ointment

First Aid Antibiotic Ointment

Protection against infection

First aid treatment for minor cuts, scrapes and burns



NET WT. 0.33 OZ.  (9.4 g)

Distributed by: PERSONAL CARE PRODUCTS, LLC
Troy, Michigan 48084 U.S.A.

Code No. MH/DRUGS/KD-313               Made in India


PC TripleAB1 Label

PC TripleAB4 Label




TRIPLE ANTIBIOTIC  EXTRA STRENGTH
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2436
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 9.4 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 9.4 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 9.4 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
CERESIN (UNII: Q1LS2UJO3A)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPANEDIOL (UNII: 5965N8W85T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29500-2436-19.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/10/2013
Labeler - Personal Care Products, Inc. (966155082)
Registrant - Personal Care Products, Inc. (966155082)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(29500-2436)

Revised: 7/2013
Document Id: 629d8eeb-d02d-4c7d-87e6-40542a82d989
Set id: ea3de90e-50a9-48b4-9a92-20b789bd7ae0
Version: 1
Effective Time: 20130711
 
Personal Care Products, Inc.