Active Ingredients
Benzalkonium Chloride 0.1%
Benzocaine 5.0%
Antiseptic
FDA Label NDC 69103-5300
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Provision Medical for the product Antiseptic (NDC 69103-5300). 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 active ingredients, purpose, uses, warnings, do not use, otc - keep out of reach of children, otc - stop use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 a doctor if condition persists or gets worse
Directions
- clean affected area 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 – 2 Fl. Oz Packet Label
The Provision
First Aid
Line™
Antiseptic Spray
For Temporary Pain
Relief and to Help
Prevent Infection in
Minor Cuts, Scrapes
and Abrasions.
2 fl. oz. (59.1 ml)
Reorder no. 3501
Principal Display Panel – 2 Fl. Oz Packet Label (Pro25 0000 01)
* Please review the disclaimer below.
