FDA Label for Antiseptic

View Indications, Usage & Precautions

Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Safetec Of America, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts


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


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