Antiseptic Skin Cleanser
FDA Label NDC 0116-0228

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Xttrium Laboratories, Inc. for the product Antiseptic Skin Cleanser (NDC 0116-0228). 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

skin wound and general skin cleaning

Warnings

For external use only


Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

wheezing/difficulty breathing

  • shock
  • facial swelling
  • hives
  • rash

    • If an allergic reaction occurs, stop use and seek medical help right away

Do Not Use

  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in the genital area

When Using This Product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in tge eye or may cause deafness when instilled on the middle ear through perforated eardrums.
  • 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 advised by a healthcare provider

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

Warning

This product contains a chemical known to the State of California to cause cancer.

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 vigorous manner for about 15 seconds
    • rinse and dry thoroughly

      • 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)

Inactive Ingredients

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

Questions Of Comments?

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST.

Package Label And Principal Display Panel

Premier Value

NDC 68016-228-00

Antiseptic Skin Cleanser

Antiseptic/Antimicrobial Skin Cleanser

(Chlorhexidine Gluconate 4% solution)

FOR EXTERNAL USE ONLY

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

8FL OZ. (237 mL) BOTTLE

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