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)

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Package Labeling: (54312-019-14)

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Package Labeling:

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Package Labeling:

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VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC 
neomycin sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54312-019-351 in 1 CARTON07/30/2016
114 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:54312-019-311 in 1 CARTON07/30/2016
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00407/30/2016
Labeler - Compania Internacional de Comercio, S.A.P.I de C.V. (822165213)
Establishment
NameAddressID/FEIBusiness Operations
Compania Internacional de Comercio, S.A.P.I de C.V.822165213manufacture(54312-019)

Revised: 10/2023
Document Id: 08c13282-54b1-52a8-e063-6394a90a5c1d
Set id: ba7a3331-466e-496f-bebd-9ee7067bcdb2
Version: 17
Effective Time: 20231028
 
Compania Internacional de Comercio, S.A.P.I de C.V.