Other
Drug Facts
Antiseptic Spray
FDA Label NDC 61010-5300
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, Inc. for the product Antiseptic (NDC 61010-5300). 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 ingredients, purpose, uses, warnings, do not use, otc - keep out of reach of children, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Benzalkonium Chloride 0.1%
Benzocaine 5.0%
Purpose
First Aid Antiseptic
Topical Pain Relief
Uses
First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns
Warnings
For external use only. Flammable keep away from fire or flame.
Do Not Use
- near eyes or mucous membranes
- on deep or puncture wounds, animal bites, or serious burns
- over large areas of the body
- more than one week unless directed by a doctor
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask doctor if condition persists or gets worse
Directions
- clean affected and spray 1 to 3 times daily
- may be covered with a sterile bandage
- children under 2 ask a doctor.
Inactive Ingredients
isopropyl alcohol, purified water
Principal Display Panel – Bottle Label
NDC 61010-5300-0
Safetec
Cut & Scrape
Antiseptic Spray
For Temporary Pain
Relief and to Help
Prevent Infection in
Minor Cuts, Scrapes
and Abrasions.
2 fl. oz. (59.1ml)
Reorder no. 53000
Principal Display Panel – Bottle Label (Cut04 0001 01)
* Please review the disclaimer below.
