POMADA SULFA FIRST AID ANTIBIOTIC- neomycin sulfate ointment
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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Grandall (as PLD) - POMADA SULFA FIRST AID ANTIBIOTIC (48201-103)

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 ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48201-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:48201-103-11	40 g in 1 JAR; Type 0: Not a Combination Product	02/06/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	02/06/2020

Labeler - Grandall Distributing Co., Inc. (044428324)

Revised: 8/2023

Document Id: 031f4df4-dcff-63f5-e063-6294a90a3444

Set id: c8181ad8-6e51-4d3f-857c-056821e9aad0

Version: 4

Effective Time: 20230817

Grandall Distributing Co., Inc.