NDC Code(s) : 66715-5505-0, 66715-6705-4, 66715-6705-0
Packager : Lil Drug Store Products, Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Circle K Triple Antibioticbacitracin zinc, polymyxin b sulfate, and neomycin sulfate ointment OINTMENT
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-5505
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC(UNII: 89Y4M234ES)
(BACITRACIN - UNII:58H6RWO52I)
BACITRACIN400 [iU]
POLYMYXIN B SULFATE(UNII: 19371312D4)
(POLYMYXIN B - UNII:J2VZ07J96K)
POLYMYXIN B5000 [iU]
NEOMYCIN SULFATE(UNII: 057Y626693)
(NEOMYCIN - UNII:I16QD7X297)
NEOMYCIN3.5 mg
Inactive Ingredients
Ingredient Name Strength
PETROLATUM(UNII: 4T6H12BN9U)
SODIUM PYRUVATE(UNII: POD38AIF08)
COTTONSEED OIL(UNII: H3E878020N)
COCOA BUTTER(UNII: 512OYT1CRR)
OLIVE OIL(UNII: 6UYK2W1W1E)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66715-5505-01 in 1 CARTON 26/05/2021
114.2 in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M004 05/26/2021 04/25/2026
Circle K Triple AntibioticBacitracin zinc, Polymyxin B sulfate, and Neomycin sulfate OINTMENT
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6705
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC(UNII: 89Y4M234ES)
(BACITRACIN - UNII:58H6RWO52I)
BACITRACIN400 [iU] in 1 g
POLYMYXIN B SULFATE(UNII: 19371312D4)
(POLYMYXIN B - UNII:J2VZ07J96K)
POLYMYXIN B5000 [iU] in 1 g
NEOMYCIN SULFATE(UNII: 057Y626693)
(NEOMYCIN - UNII:I16QD7X297)
NEOMYCIN3.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
COCOA BUTTER(UNII: 512OYT1CRR)
COTTONSEED OIL(UNII: H3E878020N)
OLIVE OIL(UNII: 6UYK2W1W1E)
SODIUM PYRUVATE(UNII: POD38AIF08)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PETROLATUM(UNII: 4T6H12BN9U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66715-6705-41 in 1 CARTON 10/10/2017
114.2 g in 1 TUBE Type 0: Not a Combination Product
2NDC:66715-6705-01 in 1 CARTON 04/01/2019
214.2 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M004 10/10/2017

LABELER - Lil Drug Store Products, Inc(093103646)

PRINCIPAL DISPLAY PANEL

24 HOUR
Infection Protection

Help Prevent Infection in
Minor Cuts, Scrapes and Burns

CIRCLE K ®

Compare to the Active
Ingredients in Neosporin ®*

Triple Antibiotic Ointment
Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate
First Aid Antibiotic Ointment

NET WT 0.5 oz (14.2 g)

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

PRINCIPAL DISPLAY PANEL

CIRCLE K™

triple antibiotic ointment

Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate First Aid Antibiotic Ointment

net wt 0.5 oz (14.2 g)

Carton PDP/Package