SCHEIN TRIPLE ANTIBIOTIC- neomycin sulfate, polymyxin b sulfate, bacitracin zinc ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)

Available from:

Henry Schein, Inc.

INN (International Name):

NEOMYCIN sulfate

Composition:

NEOMYCIN 3.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

PURPOSE: First aid antibiotic First aid to help prevent infection in minor cuts, burns, scrapes

Authorization status:

OTC monograph final

Summary of Product characteristics

SCHEIN TRIPLE ANTIBIOTIC- NEOMYCIN SULFATE, POLYMYXIN B SULFATE,
BACITRACIN
ZINC OINTMENT
HENRY SCHEIN, 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._
----------
DRUG FACTS
ACTVE INGREDIENTS: IN EACH GRAM-NEOMYCIN SULFATE-5 MG (EQUIVALENT
TO 3.5
MG NEOMYCIN), POLYMYXIN B SULFATE-5000 I.U., BACITRACIN ZINC-400 I.U.
PURPOSE: First aid antibiotic
First aid to help prevent infection in minor cuts, burns, scrapes
For external use only. Do not use on eyes. Do not use if you are
allergic to any of the
ingredients due to the possibility of anaphylactic shock.
Stop use and ask a doctor before use in cases of deep puncture wounds,
animal bites,
serious burns; if the condition persists or gets worse; if a rash or
other allergic reaction
developes
If swallowed get medical help or contact a poison control center right
away
KEEP OUT OF THE REACH OF CHILDREN
Clean the affected area. apply a small amount of product ( an amount
equal to the
surface area of the tip of a finger) on the area 1-3 times daily. May
be covered with a
sterile bandage.
INACTIVE INGREDIENT: WHITE PETROLATUM
SCHEIN TRIPLE ANTIBIOTIC
neomycin sulfate, polymyxin b sulfate, bacitracin zinc ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:0404-0360
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)
NEOMYCIN
3.5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B -
UNII:J2VZ 07J96K)
POLYMYXIN B
5000 [iU] in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)
BACITRACIN
400 [iU] in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
PETROLATUM (UNII: 4T6H12BN9U)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:0404-0360-
47
144 in 1 BOX
04/21/2015
1
NDC:0404-0360-
09
0.9 g in 1 PACK