VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC- neomycin sulfate ointment 
Compania Internacional de Comercio, S.A.P.I de C.V.

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.

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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 finalpart333B07/30/2016
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: 1/2022
Document Id: d553cb87-97a2-6698-e053-2995a90a8529
Set id: ba7a3331-466e-496f-bebd-9ee7067bcdb2
Version: 15
Effective Time: 20220111
 
Compania Internacional de Comercio, S.A.P.I de C.V.