SINGLE ANTIBIOTIC WITH NEOMYCIN- neomycin sulfate ointment

Single Antibiotic with Neomycin by

Drug Labeling and Warnings

Single Antibiotic with Neomycin by is a Otc medication manufactured, distributed, or labeled by Safetec of America, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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, and burns.

Warnings:

For external use only.

Keep out of reach of children.

If ingested, get medical help or contact a Poison Control Center directly.

Do Not Use:

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

Stop use, ask a doctor if:

• condition persists or gets worse
• a rash or allergic reaction develops

Directions:

• clean affected area
• apply a small amount of this product (equal to the surface area of the tip of finger) 1 to 3 times daily
• may cover with a sterile bandage

Inactive ingredients:

mineral oil, petrolatum

Questions or Comments? 1-800-456-7077

Principal Display Panel - Box Label

NDC: 61010-6700-2

Safetec

First Aid

Single Antibiotic Ointment

• with Neomycin
• First Aid to Help Prevent
  Infection In Minor Cuts,
  Scrapes, and Burns

Reorder No. 53610

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Principal Display Panel - Pouch Label

Safetec

Single Antibiotic
Ointment

(Neomycin)

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Principal Display Panel - Box Label

NDC: 61010-6700-3

Safetec

First Aid

Single Antibiotic Ointment

• with Neomycin
• First Aid to Help Prevent
  Infection In Minor Cuts,
  Scrapes, and Burns

25 Packets

Each Packet Net. Wt. 0.9gm

Principal Display Panel - Pouch Label

Safetec

Single Antibiotic
Ointment

(Neomycin)

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

INGREDIENTS AND APPEARANCE

SINGLE ANTIBIOTIC WITH NEOMYCIN 
neomycin sulfate ointment

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-6700-2	144 in 1 BOX	11/13/2008
1	NDC: 61010-6700-1	0.9 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 61010-6700-3	25 in 1 BOX	11/13/2008
2	NDC: 61010-6700-1	0.9 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	11/13/2008

Labeler - Safetec of America (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(61010-6700)