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Drug Facts
Single Antibiotic With Bacitracin Ointment
FDA Label NDC 61010-5601
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America for the product Single Antibiotic With Bacitracin (NDC 61010-5601). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each gram), purpose, uses:, otc - keep out of reach of children, do not use:, stop use, ask a doctor if:, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Gram)
Bacitracin zinc (500 units bacitracin)
Purpose
First Aid Antibiotic
Uses:
First aid to help prevent infection in minor cuts, scrapes, and burns.
Otc - Keep Out Of Reach Of Children
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 61010-5601-2
Safetec
First Aid
Single Antibiotic Ointment
• with Bacitracin
• First Aid to Help Prevent
Infection In Minor Cuts,
Scrapes, and Burns
Reorder No. 53310
To reorder:
Call: 1-800-456-7077
Fax: 716-895-2969
Online: www.safetec.com
Principal Display Panel (Box Label)
NDC 61010-5601-3
Safetec
First Aid
Single Antibiotic Ointment
• with Bacitracin
• First Aid to Help Prevent
Infection In Minor Cuts,
Scrapes, and Burns
25 Packets
Each Packet Net. Wt. 0.9gm
Principal Display Panel (Box Label)
Principal Display Panel - Pouch Label
Safetec
Single Antibiotic
Ointment
(Bacitracin)
0.9 g (1/32 oz.)
Safetec of America, Inc.
Buffalo, NY 14215
800-456-7077
Principal Display Panel (Pouch Label)
Safetec
Single Antibiotic
Ointment
(Bacitracin)
0.9 g (1/32 oz.)
Safetec of America, Inc.
Buffalo, NY 14215
800-456-7077
Principal Display Panel (Pouch Label)
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