Aplicare Antiseptic Chlorhexidine Gluconate
FDA Label NDC 52380-1274

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aplicare, Inc. for the product Aplicare Antiseptic Chlorhexidine Gluconate (NDC 52380-1274). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient

Chlorhexidine Gluconate 2% solution

Otc - Purpose

Purpose

Surgical hand scrub

Healthcare personnel handwash

Patient preoperative skin preparation

Skin wound and general skin cleansing

Warnings

WarningFor external use only

Otc - Do Not Use

Do not use

  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • in contact with meninges
  • in the genital area
  • as a preoperative skin prep of the head or face

Otc - When Using

When using this product

  • keep out of eyes, ears and mouth.  May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when installed in the middle ear through perforated ear drums.
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of the skin

Otc - Stop Use

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs.  This may be signs of a serious condition.

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.

Dosage & Administration

Directions

Surgical hand scrub

  • wet hands and forearms under running water
  • scrub for 3 minutes with about 5 ml of product and a wet brush paying close attention to the nails, cuticles and interdigital spaces
  • a separate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 ml of product and rinse under running water
  • dry thoroughly
    • Healthcare personnel handwash
    • wet hands with water
    • dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds
    • rinse and dry thoroughly
      • Patient preoperative skin preparation
      • apply product liberally to surgical site and swab for at least 2 minutes
      • dry with a sterile towel
      • repeat procedure for an additional 2 minutes and dry with a sterile towel
        • Skin wound and general skin cleansing
        • thoroughly rinse the area to be cleaned with water
        • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
        • rinse again thoroughly

Otc - Questions

Questions or comments?

1-800-760-3236 (Mon.-Fri. 8:30AM - 5:00 PM EST)

Package Label.Principal Display Panel

2% Chlorhexidine Gluconate, 4 oz.

2% Chlorhexidine Gluconate, 4 Oz. (L319 0206)

2% Chlorhexidine Gluconate, 4 Oz. (L319 0206)

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