VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC- neomycin sulfate ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)

Available from:

Compania Internacional de Comercio, S.A.P.I de C.V.

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN 3.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First aid to help prevent infection in minor cuts, scrapes, and burns.

Authorization status:

OTC monograph final

Summary of Product characteristics

VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC- NEOMYCIN
SULFATE OINTMENT
COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.
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VITACILINA NEOMYCIN SULFATE OINTMENT FIRST AID ANTIBIOTIC
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH GRAM)_
Neomycin sulfate 5 mg (neomycin 3.5 mg)
_PURPOSE_
First aid antibiotic
USES
First aid to help prevent infection in minor cuts, scrapes, and burns.
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
• in the eyes • over large areas of the body • if you are
allergic to any of the ingredients
• longer than 1 week unless directed by a doctor
ASK A DOCTOR BEFORE USE IF YOU HAVE
• deep or puncture wounds • animal bites • serious burns
STOP USE AND ASK A DOCTOR IF
• the condition persists or gets worse • a rash or other allergic
reaction develops
KEEP OUT OF THE REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
• Clean the affected area • Apply a small amount of this product
(an amount equal to
the surface area of the tip of a finger) on the area 1 to 3 times
daily • May be covered
with a sterile bandage
_OTHER INFORMATION_
store at room temperature
_INACTIVE INGREDIENTS_
lanolin, methylparaben, petrolatum, propylparaben, vitamin A palmitate
PACKAGE LABELING: (54312-019-35)
PACKAGE LABELING: (54312-019-14)
PACKAGE LABELING:
PACKAGE LABELING:
VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC
neomycin sulfate ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:54312-019
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
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:54312-019-
35
1 in 1 CARTON
07/3