Active Ingredient
Neomycin Sulfate 0.556%
Roosin Neomycin Antibiotic
FDA Label NDC 81552-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roosin Medical Co., Ltd for the product Roosin Neomycin Antibiotic (NDC 81552-001). 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 active ingredient, purpose, use, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antibiotic
Use
First aid to help prevent infection in minor cuts scrapes burns
Warnings
For external use only
Otc - Do Not Use
Do not use
- In eyes
- Over large areas of the body
- For more than one week unless directed by a doctor
- If you are allergic to any of the ingredients
Otc - Ask Doctor
Ask doctor before use if you have puncture wounds, animal bites, or serious burns
Otc - Stop Use
Stop use an ask a doctor ifÂ
- A rash or allergic reaction develops
- Condition worsens or persists
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If ingested, get medical help or contact a poison control center right away
Directions
Clean affected area
Apply a small amount 1-3 times daily
May cover with a sterile bandage
Other Information
Store at room temperatuure
Inactive Ingredients
Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water
Package Label.Principal Display Panel
Image Description (20210416 02)
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