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Antiseptic skin cleanser - Medication Information

Product NDC Code 0363-1061
Drug Name

Antiseptic skin cleanser

Type Brand
Pharm Class Decreased Cell Wall Integrity [PE]
Active Ingredients
Chlorhexidine gluconate 4 mg/100ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 211365
Application Number NDA019125
Labeler Name Walgreen Co.
Packages
Package NDC Code Description
0363-1061-08 237 ml in 1 bottle, plastic (0363-1061-08)
0363-1061-15 15 ml in 1 kit (0363-1061-15)
0363-1061-16 473 ml in 1 bottle, pump (0363-1061-16)
0363-1061-18 532 ml in 1 bottle, pump (0363-1061-18)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Chlorhexidine gluconate 4% Solution

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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

Purpose

Information about the drug product’s indications for use.
Purpose Antiseptic

Spl product data elements

Usually a list of ingredients in a drug product.
Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% LAURAMINE OXIDE COCO DIETHANOLAMIDE PEG-75 LANOLIN HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) ISOPROPYL ALCOHOL WATER TRIDECYL ALCOHOL GLUCONOLACTONE CHLORHEXIDINE GLUCONATE CHLORHEXIDINE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package label and principal display panel Well at Walgreens NDC 0363-1061-08 Walgreens Pharmacist Recommended‡ Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% Solution/Antiseptic/Antimicrobial Skin Cleanser Compare to the active ingredient in Hibiclens®‡‡ 8 FL OZ. (237 mL) TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING. 4WA08BTLLBLF Well at Walgreens NDC 0363-1061-16 Walgreens Pharmacist Recommended‡ Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% Solution/Antiseptic/Antimicrobial Skin Cleanser Compare to the active ingredient in Hibiclens®‡‡ 16 FL OZ. (473 mL) TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING. 4WA16BTLLBLC Walgreens Dye-Free Antiseptic Foaming Skin Cleanser CHLORHEXIDINE GLUCONATE 4% SOLUTION / ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER Compare to Hibiclens® active ingredient NDC 0363-1061-18 DYE FREE Surgical hand scrub Healthcare personnel handwash Skin wound & general skin cleansing 18 FL OZ (532 mL) 4WA18FM1061LBL 8 PDP 1 2 3 4 PDPP 1-1 1-2 1-3 1-4 4WA18 PDP 4WA18 DF1 4WA18 DF2 4WA18 DF3 Carton NDC 0363-1061-15 Walgreens, Co. Chlorhexidine Gluconate 4% Solution Antiseptic Skin Cleansing Kit Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 4WAL15INNERCTN 0.5 FL OZ (15 mL) Walgreens 15mL CTN Page 1 Walgreens 15mL CTN Page 2 Walgreens 15mL CTN Page 3 Walgreens 15mL CTN Page 4 Lidstock NDC 0363-1061-15 Walgreens, Co. Chlorhexidine Gluconate 4% Solution Antiseptic Skin Cleansing Kit Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 4WAL15LIDSTOCK 0.5 FL OZ (15 mL) Walgreens 15mL LDSK Page 1 Walgreens 15mL LDSK Page 2 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 4WAL15PACKET 0.5 FL OZ (15 mL) Walgreens 15mL PP Page 1 Walgreens 15mL PP Page 2

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use if you of 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

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine-releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents. W ARNING: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer. ‡Walgreens Pharmacist Survey Study, November 2014 ‡‡This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®. Distributed by: Walgreen Co. 200 Wilmot RD., Deerfield, IL 60015 100% Satisfaction Guaranteed walgreens.com ©2015 Walgreen Co. Made in USA

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? call 1-800-925-4733

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
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

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20-25° C (68-77°F) avoid excessive heat above 40°C (104°F)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only Allergy alert: This product may cause a severe allergic reaction. Sypmtoms 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 of 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 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 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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API