Walgreens 4% Chg

Walgreens 4% Chg
SPL v9
SPL
SPL Set ID 4ab2cfc2-7adb-20c4-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 mg)
Inactive Ingredients
Lauramine Oxide Coco Diethanolamide Peg-75 Lanolin Hydroxyethyl Cellulose (2000 Cps At 1%) Isopropyl Alcohol Water Tridecyl Alcohol Gluconolactone

Identifiers & Packaging

Marketing Status
NDA Active Since 2011-05-01

Description

Chlorhexidine gluconate 4% Solution

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate 4% Solution

Uses

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

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)

Section 43683-2

Surgical handscrub removed

Section 60561-8

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine-releasing products. 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

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)

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.

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
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
Questions?

1-800-587-3721

Active Ingredient

Chlorhexidine gluconate 4% Solution

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.

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.

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)


Structured Label Content

Uses

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

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)

Section 43683-2 (43683-2)

Surgical handscrub removed

Section 60561-8 (60561-8)

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine-releasing products. 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

Purpose

Antiseptic

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)

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.

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
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
Questions?

1-800-587-3721

Active Ingredient

Chlorhexidine gluconate 4% Solution

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

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

When Using This Product (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 (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.

Package Label and Principal Display Panel (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)


Advanced Ingredient Data


Raw Label Data

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