Antiseptic Skin Cleanser Liquid
FDA Label NDC 63868-940

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Antiseptic Skin Cleanser (NDC 63868-940). 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, when using this product, stop use and ask doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

Uses

  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing

Warnings

For external use only

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 preparation of the head or face

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 eardurms.
  • 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 skin

Stop Use And Ask Doctor If

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control center right away

Directions

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

    • Healthcare personnel handwash:

    • wet hands with water
    • dispense about 5ml of product into cupped hands and wash in a vigorous manner for about 15 seconds
    • rinse and dry thoroughly

      • Patient preoperative skin preparation:

      • apply product librally to surgical site and swab for at least 2 minutes and dry with a sterile towel
      • repeat procedure for an additional 2 minutes and dry with a sterile towel

        • Skin wound and normal 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

Other Information

  • store at 20°-25° C (68°-77° F)
  • avoid excessive heat above 40° C (104° F)

    • DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

    Warning: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.

    Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.

    *This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.

Inactive Ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions Of Comments?

call 1-800-935-2362 Monday through Friday 9:00 AM to 4:00 PM EST.

Package Label And Principal Display Panel

Quality Choice

NDC 63868-940-08

Compare to the active ingredient in HIBICLENS®*

Antiseptic Skin Cleanser

Antiseptic/Antimicrobial Skin Cleanser

Chlorhexidine Gluconate 4% Solution

Reduces Bacteria on the Skin

Net Contents: 8FL OZ (237 mL) BOTTLE

FOR EXTERNAL USE ONLY

DYE FREE

* Please review the disclaimer below.