POMADA SULFA FIRST AID ANTIBIOTIC

Drug Labeling and Warnings

Drug Details [pdf]

POMADA SULFA FIRST AID ANTIBIOTIC- neomycin sulfate gel 
Grandall Distributing Co., 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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POMADA SULFA FIRST AID ANTIBIOTIC

ACTIVE INGREDIENT

Neomycin Sulfate 0.5%

PURPOSE

FIRST AID ANTIBIOTIC

INDICATIONS

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

WARNINGS

For external use only. Do not use in the eyes or over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor. Stop use and consult a doctor if condition persists or gets worse. Do not use longer than one week unless directed by a doctor. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Store at room temperature.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

DIRECTIONS

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

INACTIVE INGREDIENTS

PETROLATUM 99.5%

01b LBL_Sulfa Edit - 01_DF

01b LBL_Sulfa Edit - 01_DF2

POMADA SULFA FIRST AID ANTIBIOTIC 
neomycin sulfate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 48201-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 48201-102-1140 g in 1 JAR; Type 0: Not a Combination Product02/06/202011/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B02/06/202011/20/2020
Labeler - Grandall Distributing Co., Inc. (044428324)

Revised: 11/2020
 
Grandall Distributing Co., Inc.