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. 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



Isopropyl Alcohol 71.5%


Purpose



Antiseptic


Uses



  • For preparation of the skin prior to injection or venipuncture

Warnings



For external use only

Flammable. Keep away from fire or flame

Do not use with electrocautery procedures or in or near the eyes. If this happens, rinse thoroughly with water.


Otc - Stop Use



Stop use and ask doctor if irritation or redness develop and persists for more than 72 hours


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


Directions



  • start at the venipuncture site and apply in a circular fashion
  • use additional wipes as necessary to cover area

Inactive Ingredients



purified/deionized water, ethyl ester of PVMA/MA copolymer, ethyl alcohol, acetyl tributyl citrate, chloroxylenol


Principal Display Panel – Packet Label



Safetec

I.V. Prep

Antiseptic/Barrier Wipe

For preparation of the skin prior to injection or venipuncture

Contents: 1 single-use, premoistened towelette

Manufactured by SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 800-456-7077 www.safetec.com


Principal Display Panel – Box



Safetec

Contents: 50 individual, single-use, premoistened towelettes

NDC 61010-7000-1

I.V. Prep

Antiseptic/Barrier Wipe

For preparation of the skin prior to injection or venipuncture


* Please review the disclaimer below.