QUALITY CHOICE MAXIMUM STRENGTH TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrochloride ointment 
Chain Drug Marketing Association 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 (in each gram)                                               Purpose

Bacitracin zinc 500 units......................................................... First aid antibiotic

Neomycin 3.5 mg.................................................................. First aid antibiotic

Polymyxin B sulfate 10,000 units............................................ First aid antibiotic

Pramoxine hydrochloride 10 mg.............................................. First aid analgesic

Uses

Helps prevent infection and temporarily relieves pains due to:

Warnings

For external use only

Allergy alert: do not use if allergic to any of the ingredients

Do not use

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if:

Keep out of reach of children. If swallowed, get medical help or contact a Poision Control Center right away.

Directions

Adults and children 2 years of age and older:

Children under 2 years of age: ask a doctor

Other information

Inactive ingredients

methylparaben, liquid paraffin, white petrolatum, polyoxyl 40 stearate, proplyparaben

DISTRIBUTED BY:

C.D.M.A., INC.

43157 W. NINE MILE

NOVI, MI 48376-0995 USA

Made in Korea

image description

QUALITY CHOICE MAXIMUM STRENGTH TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-910
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-910-011 in 1 CARTON10/12/2016
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/25/2014
Labeler - Chain Drug Marketing Association Inc (011920774)

Revised: 10/2016
Document Id: d52658cd-5cb6-4a90-a051-3684d480ea75
Set id: 624d8fb4-c1f2-4e99-a3d2-0878092e59d6
Version: 3
Effective Time: 20161012
 
Chain Drug Marketing Association Inc