Label: VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC- neomycin sulfate ointment
- NDC Code(s): 54312-019-31, 54312-019-35
- Packager: Compania Internacional de Comercio, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated August 4, 2016
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- Drug Facts
- Active ingredient (in each gram)
Neomycin sulfate 5 mg (neomycin 3.5 mg)Close
First aid to help prevent infection in minor cuts, scrapes, and burns.Close
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
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.
• 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 bandageClose
- Other information
store at room temperatureClose
- Inactive ingredients
lanolin, methylparaben, petrolatum, propylparaben, vitamin A palmitateClose
- Package Labeling:
- INGREDIENTS AND APPEARANCE
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 07/30/2016 1 14 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:54312-019-31 1 in 1 CARTON 07/30/2016 2 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 07/30/2016 Labeler - Compania Internacional de Comercio, S.A. de C.V. (815039995)