FIRST AID ONLY NEOMYCIN ANTIBIOTIC- neomycin sulfate ointment
Acme United Corporation

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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FIRST AID ONLY Neomycin Antibiotic Ointment

Drug Facts

Active Ingredient (in each gram)

Neomycin Sulfate (3.5 mg Neomycin)

Purpose

First Aid Antibiotic

Uses:

First aid to help prevent infection in minor cuts, scrapes, burns.

Use firstaid to help prevent infection in minor •scrapes •cuts •burns

Warnings:

For external use only.

Keep out of reach of children.

If swallowed, contact a Poison Control Center right away

Do Not Use:

in the eyes • over large areas of the body •on puncture wounds, animal bites or serious burns
longer than 1 week unless directed by a doctor
if you are allergic to any of the ingredients

Stop use, ask a doctor if

a rash or allergic reaction develop
condition persists or gets worse

Directions

clean affected area
apply small amount 1 to 3 times daily
may cover with a sterile bandage

Inactive ingredients:

mineral oil, petrolatum

Manufactured for:

1 Waterview Dr, Shelton, CT 06484

Pouch Label

FIRST AID ONLY NEOMYCIN ANTIBIOTIC
neomycin sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-5620(NDC:61010-6700)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0924-5620-00	0.9 g in 1 POUCH; Type 0: Not a Combination Product	07/16/2021
2	NDC:0924-5620-01	10 in 1 BOX	05/10/2023
2		0.9 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC:0924-5620-02	20 in 1 BOX	05/10/2023
3		0.9 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	07/16/2021

Labeler - Acme United Corporation (001180207)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		045924339	relabel(0924-5620) , repack(0924-5620)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		080119599	relabel(0924-5620) , repack(0924-5620)