Active Ingredient
Chlorhexidine gluconate 4% w/v
Foaming Chlorhexidine Gluconate
FDA Label NDC 71788-016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Protect U Guard, Llc for the product Foaming Chlorhexidine Gluconate (NDC 71788-016). 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, do not use, when using this product, keep out of reach of children, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
Antimicrobial skin cleanser helps reduce bacteria
for skin wound and skin cleansing
surgical hand scrub
healthcare personnel handwash
Warnings
For external use only.
Do Not Use
if you are allergic to chlorhexidine gluconate or any other ingredient(s) in this preparation
as a patient preoperative skin preparation of the head or face
in contact with the meninges or in the genital area
on wounds involving more than the superficial layers of skin
as a general skin cleanser
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 instilled in the middle ear through perforated eardrums.
if contact occurs in any of these areas, rinse with cold water right away
do not inhale or ingest
Keep Out Of Reach Of Children
If swallowed get medical help or contact a Poison Control Center right away.
Stop Use And Ask A Doctor If
irritation, sensitization, or allergic reaction occurs and lasts 72 hours. These may be signs of a serious condition.
Directions
use with care in premature infants under 2 months of age. These products may cause irritation or chemical burns.
skin wound and skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughly
surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with 5mL of the product with brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
healthcare personnel handwash. Wet hands with water. Dispense 5 mL of the product into cupped hands. Wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.
Other Information
May discolor some fabrics. Do not use with bleach.
Store between 20-25° C ( 68-77° F). Avoid excessive heat.
Inactive Ingredients:
Water, lauramine oxide, isopropyl alcohol, gluconolactone.
Questions Or Comments?
1-813-815-0530 or www.protectuguard.com
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