QUALITY CHOICE MAXIMUM STRENGTH TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and 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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QC Max Strength Triple Antibiotic Ointment 1 oz. 94594 CMI 2019

Active ingredient (in each gram) Purposes

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

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

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

Pramoxine HCI 10 mg.............................................................External analgesic

Uses

Warnings

For external use only

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

cetyl alcohol, light mineral oil, polyoxyl 40 stearate, stearic acid, white petrolatum

Distributed by:

C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Made in South Korea

PH

QUALITY CHOICE MAXIMUM STRENGTH TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
PETROLATUM (UNII: 4T6H12BN9U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-009-281 in 1 CARTON12/19/2019
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 finalpart333B12/19/2019
Labeler - Chain Drug Marketing Association Inc (011920774)

Revised: 12/2019
Document Id: 9a130895-d96a-4fa8-e053-2995a90a4468
Set id: 9a130895-d969-4fa8-e053-2995a90a4468
Version: 1
Effective Time: 20191219
 
Chain Drug Marketing Association Inc