Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% XTTRIUM LABORATORIES, INC. FDA Approved Uses healthcare personnel handwash : helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing
FunFoxMeds box
Route
TOPICAL
Applications
NDA019125

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 532 ml 473 ml 15 ml 15 pack
Treats Conditions
Uses Healthcare Personnel Handwash Helps Reduce Bacteria That Potentially Can Cause Disease Skin Wound And General Skin Cleansing

Identifiers & Packaging

Container Type BOX
UPC
0311917182728
UNII
MOR84MUD8E
Packaging

Package label and principal display panel Walgreens Compare to the Hibiclens® active ingredient NDC 0363-1061-08 Dye-Free Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% SOLUTION / ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER DYE FREE TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING 8 FL OZ (237 mL) NDC 0363-1061-18 Walgreens Compare to Hibiclens® active ingredient Dye-Free Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% SOLUTION / ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING 18 FL OZ (532 mL) NDC 0363-1061-16 Walgreens Compare to Hibiclens® active ingredient Dye-Free Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% SOLUTION / ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING 16 FL OZ (473 mL) Wal 8oz wal 18oz wal 16oz; Carton NDC 0363-1061-15 Walgreens, Co. Chlorhexidine Gluconate 4% Solution Antiseptic Skin Cleansing Kit Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 4WAL15INNERCTNA 0.5 FL OZ (15 mL) CTN Page 1 CTN Page 2 CTN Page 3; Lidstock NDC 0363-1061-15 Walgreens, Co. Chlorhexidine Gluconate 4% Solution Antiseptic Skin Cleansing Kit Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 4WAL15LIDSTOCKA 0.5 FL OZ (15 mL) LDSK; Packet NDC 0363-1061-15 Walgreens, Co. Chlorhexidine Gluconate 4% Solution Antiseptic Skin Cleansing Convenience Kit Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 4WAL15PACKETA 0.5 FL OZ (15 mL) PP Page 1 PP Page 2

Package Descriptions
  • Package label and principal display panel Walgreens Compare to the Hibiclens® active ingredient NDC 0363-1061-08 Dye-Free Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% SOLUTION / ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER DYE FREE TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING 8 FL OZ (237 mL) NDC 0363-1061-18 Walgreens Compare to Hibiclens® active ingredient Dye-Free Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% SOLUTION / ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING 18 FL OZ (532 mL) NDC 0363-1061-16 Walgreens Compare to Hibiclens® active ingredient Dye-Free Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% SOLUTION / ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING 16 FL OZ (473 mL) Wal 8oz wal 18oz wal 16oz
  • Carton NDC 0363-1061-15 Walgreens, Co. Chlorhexidine Gluconate 4% Solution Antiseptic Skin Cleansing Kit Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 4WAL15INNERCTNA 0.5 FL OZ (15 mL) CTN Page 1 CTN Page 2 CTN Page 3
  • Lidstock NDC 0363-1061-15 Walgreens, Co. Chlorhexidine Gluconate 4% Solution Antiseptic Skin Cleansing Kit Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 4WAL15LIDSTOCKA 0.5 FL OZ (15 mL) LDSK
  • Packet NDC 0363-1061-15 Walgreens, Co. Chlorhexidine Gluconate 4% Solution Antiseptic Skin Cleansing Convenience Kit Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 4WAL15PACKETA 0.5 FL OZ (15 mL) PP Page 1 PP Page 2

Overview

Uses healthcare personnel handwash : helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing

Indications & Usage

Uses 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. 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 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

Warnings & Precautions
Warnings For external use only Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing 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 pemitted to ener and remain in the eye or may cause deafness when instilled in the middle eat 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 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. If swallowed, get medical help or contact a Poison Control Center right away.
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 pemitted to ener and remain in the eye or may cause deafness when instilled in the middle eat 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? 1-800-587-3721


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