VITACILINA- neomycin ointment 
Teresa Cecena DBA Genesis

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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NEOMYCIN SULFATE 5mg

PURPOSE

Antibootic

USES

Frist aid to help prevent infection in* minor cuts*scrapes*burns

Warnings

For external Use only

DO NOT USE

In the eyes or apply over large areas of the body

Longer that a weel unless directed by doctor

Stop Use

And consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops

In case of accidental ingestion, seek professional assistance or contac a poison control center immediately.

Directions

Clean the affected area. Apply a small amout of the product ( an amount equeal to the surface area of the tip of finger) on the area 1 to 3 times daily. May be covered with a sterile bandage.

Clean the affected area. Aplly a small amount of the product on the area 1 to 3 times daily.

May be covered with a sterile bandage

Lanolin, Methylparaben, Petrolatum, propylparaben, vitamin A palmitate

Vitacilina

VITACILINA 
neomycin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-019
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)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69772-019-351 in 1 CARTON05/15/2015
114 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69772-019-311 in 1 CARTON05/20/2015
228 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:69772-019-321 in 1 CARTON02/03/2017
332 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B05/15/2015
Labeler - Teresa Cecena DBA Genesis (078760958)
Registrant - Teresa Cecena (078760958)
Establishment
NameAddressID/FEIBusiness Operations
Teresa Cecena DBA Genesis078760958relabel(69772-019)
Establishment
NameAddressID/FEIBusiness Operations
Farmaqro SA de CV588161468manufacture(69772-019)

Revised: 2/2017
Document Id: 47a64219-8df3-21e8-e054-00144ff88e88
Set id: 1622ca25-3f6d-6158-e054-00144ff88e88
Version: 3
Effective Time: 20170203
 
Teresa Cecena DBA Genesis