AFTATE TRIPLE ANTIBIOTIC (TRIPLE ANTIBIOTIC OINTMENT) OINTMENT [SABEL MED LLC]

AFTATE TRIPLE ANTIBIOTIC (TRIPLE ANTIBIOTIC OINTMENT) OINTMENT [SABEL MED LLC]
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NDC	70356-101-01, 70356-101-05, 70356-101-33
Set ID	2f6e9a84-895c-492d-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	Sabel Med LLC
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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DOSAGE & ADMINISTRATION
INDICATIONS & USAGE
WARNINGS
KEEP OUT OF REACH OF CHILDREN
ACTIVE INGREDIENT
INACTIVE INGREDIENT
PURPOSE
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AFTATE TRIPLE ANTIBIOTIC
triple antibiotic ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70356-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU] in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	400 [iU] in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70356-101-01	28 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2016
2	NDC:70356-101-05	14 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2016
3	NDC:70356-101-33	9.4 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	05/01/2016

Labeler - Sabel Med LLC (091476000)

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