Surgicept
FDA Label NDC 0064-1080

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Healthpoint, Ltd for the product Surgicept (NDC 0064-1080). 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, uses, warnings, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Ethyl alcohol 70% w/w

Purpose

Antiseptic

Uses

  • Surgical Hand Scrub:  Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care.
  • Healthcare Personnel Handwash:  Handwash to help reduce bacteria that potentially can cause disease.  Recommended for repeated use.

Warnings

  • Flammable, keep away from fire or flame.
  • For external use only.
  • Do not use
    • if you are allergic to or have a known or suspected hypersensitivity to any ingredient in this product.
    • on or near the eyes, mucous membranes or mouth.  If product gets into the eyes, flush immediately with water.
    • Stop use and ask a doctor if irritation, redness or allergic reaction occurs.
    • Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Behentrimonium methosulfate, benzalkonium chloride, butylene glycol, cetyl alcohol, chlorhexidine gluconate, ethylhexylglycerin, isopropyl alcohol, phenoxyethanol, polyquaternium-10, PPG-3 myristyl ether, water.

Questions?

Please call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST) or visit our web site www.surgicept.com.

PRINCIPAL DISPLAY PANEL

NDC 0064-1080-59

Surgicept ®

Ethyl alcohol 70% w/w

WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash

2 fl oz (59 ml)
129464-1010

Marketed by:
CareFusion, Leawood, KS 66211

Manufactured for:
Healthpoint, Ltd., Fort Worth, TX 76107
by DPT Laboratories, Ltd., San Antonio, TX 78215

REORDER NO. 0064-1080-59
PATENT NO. 6,846,846

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