Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% TOPCO ASSOCIATES LLC FDA Approved Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing
FunFoxMeds box
Route
TOPICAL
Applications
NDA019125
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient Chlorhexidine Gluconate 4% Solution
Inactive Ingredients
Inactive ingredients cocamide DEA fragrance glucono-delta-lactone hydroxyethylcellulose isopropyl alcohol lauramine oxide PEG-75 lanolin purified water tridecyl alcohol.
Strengths
4 %
Quantities
237 ml
Treats Conditions
Uses Surgical Hand Scrub Significantly Reduces The Number Of Microorganisms On The Hands And Forearms Prior To Surgery Or Patient Care Healthcare Personnel Handwash Helps Reduce Bacteria That Potentially Can Cause Disease Skin Wound And General Skin Cleansing

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
MOR84MUD8E
Packaging

Package label and principal display panel NDC 36800-401-50 TopCare® health™ COMPARE TO HIBICLENS® ACTIVE INGREDIENT* DYE FREE Antiseptic Skin Cleanser (CHLORHEXIDINE GLUCONATE 4% SOLUTION) ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER FOR EXTERNAL USE ONLY 8 FL OZ (237 mL) TOPCO08 PDP TOPCO08 DF1 TOPCO08 DF2 TOPCO08 DF3

Package Descriptions
  • Package label and principal display panel NDC 36800-401-50 TopCare® health™ COMPARE TO HIBICLENS® ACTIVE INGREDIENT* DYE FREE Antiseptic Skin Cleanser (CHLORHEXIDINE GLUCONATE 4% SOLUTION) ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER FOR EXTERNAL USE ONLY 8 FL OZ (237 mL) TOPCO08 PDP TOPCO08 DF1 TOPCO08 DF2 TOPCO08 DF3

Overview

Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing

Indications & Usage

Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing

Dosage & Administration

Directions use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. 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 about 15 seconds rinse and dry thoroughly 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

Warnings & Precautions
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 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. These may be signs of a serious condition. 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 the eye or may cause deafness when instilled in 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 health care provider
Purpose

Purpose Antiseptic

Do Not Use

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

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 the eye or may cause deafness when instilled in 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 health care provider

Stop Use & Ask a Doctor

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

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.

Storage & Handling

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

Questions

Questions of comments? call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST


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