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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Antibiotic Ointment

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

NDC NO. 53210-1003-0
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

tube label

ANTIBIOTIC  
neomycin sulfate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53210-1003
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL (UNII: T5L8T28FGP)  
SQUALANE (UNII: GW89575KF9)  
LANOLIN (UNII: 7EV65EAW6H)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53210-1003-0 1 in 1 BOX
1 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 09/25/2012
Labeler - Morales Distributors Inc (127151731)

Revised: 9/2012
Document Id: e90595b3-d065-4c09-afbd-7c3ae3e95bd4
Set id: 695bfb1f-4648-458b-bab5-30dc3ff8748d
Version: 4
Effective Time: 20120928
 
Morales Distributors Inc