ANTIBIOTIC   - neomycin sulfate ointment 
Morales Distributors Inc

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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Active ingredients (in each gram)

Neomycin Sulfate 3.5mg

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in minor:

Warnings

For external use only

Do not use

Consult a doctor in case of

Stop use and ask a doctor if

Keep out of reach of children

in case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Other information

store at room temperature

Inactive ingredients

Liquid paraffin, Cethanol, Squalane, Purified lanolin, White petrolatum, Cetearyl alcohol, Tocopheryl acetate, Methylparaben, Propylparaben

Package label

Compare to Vitacilinia First Aid Antibiotic active ingredient

MAXIMUM STRENGTH

ANTIBIOTIC OINTMENT
Neomycin Sulfate
FIRST AID ANTIBIOTIC OINTMENT

Net 1 oz (28.3g)

Exclusively distributed by:
Morales Distributors, Inc.
Mayaguez, P.R. 00682

Made in Korea


package box label

package box label


ANTIBIOTIC  
neomycin sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53210-1003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
SQUALANE 
LANOLIN 
PETROLATUM 
CETOSTEARYL ALCOHOL 
.ALPHA.-TOCOPHEROL ACETATE 
METHYLPARABEN 
PROPYLPARABEN 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:53210-1003-01 TUBE ( TUBE) in 1 BOXcontains a TUBE
128 g in 1 TUBEThis package is contained within the BOX (53210-1003-0)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/25/2012

Labeler - Morales Distributors Inc (127151731)

Revised: 09/2012 Morales Distributors Inc