Drug Facts

Composition & Product

Active Ingredients

Chlorhexidine (0.75 mg)

Inactive Ingredients

Coco Diethanolamide Hydroxyethyl Cellulose (140 Cps At 5%) Isopropyl Alcohol Lauramine Oxide Ricinoleamidopropyltrimonium Chloride Water Citric Acid Monohydrate Fd&c Yellow No. 5 Fd&c Red No. 4

Identifiers & Packaging

Marketing Status

NDA Active Since 2014-09-30

Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate solution, 0.75%

Use

healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

Section 60561-8

Keep from freezing.

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.

Directions

use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.

Do Not Use

if you are allergic to chlorhexidine gluconate or any other ingredient in this product

Active Ingredient

Chlorhexidine gluconate solution, 0.75%

Other Information

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

Inactive Ingredients

citric acid, cocamide DEA, FD&C yellow #5, FD&C red #4, fragrance, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water, ricinoleamidopropyl trimethyl ammonium chloride

Questions Or Comments?

call 1-800-581-2528, 24 hours a day, 7 days a week

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
do not use routinely if you have wounds which involve more than the superficial layers of the skin

Stop Use and Ask A Doctor If

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Healthcare Personnel Handwash:

wet hands with water
dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds
rinse and dry thoroughly

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel

Dr. Dean

Chlorhexidine Gluconate

Solution

0.75%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamedicalsupply.com

4 fl oz (118 mL)

NDC 81657-001-01

MADE IN THE USA

FDA APPROVED

California Prop 65 WARNING

Keep from freezing.

Dr. Dean

Chlorhexidine Gluconate

Solution

0.75%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamedicalsupply.com

8 fl oz (236 mL)

NDC 81657-001-02

MADE IN THE USA

FDA APPROVED

California Prop 65 WARNING

Keep from freezing.

Dr. Dean

Chlorhexidine Gluconate

Solution

0.75%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamedicalsupply.com

8 fl oz (236 mL)

NDC 81657-001-04

MADE IN THE USA

FDA APPROVED

California Prop 65 WARNING

Keep from freezing.

Dr. Dean

Chlorhexidine Gluconate

Solution

0.75%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamedicalsupply.com

128 fl oz (3785 mL)

NDC 81657-001-03

MADE IN THE USA

FDA APPROVED

California Prop 65 WARNING

Keep from freezing.

Structured Label Content

Use

healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

Section 60561-8 (60561-8)

Keep from freezing.

Purpose

Antiseptic

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.

Directions

use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.

Do Not Use (Do not use)

if you are allergic to chlorhexidine gluconate or any other ingredient in this product

Active Ingredient (Active ingredient)

Chlorhexidine gluconate solution, 0.75%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

citric acid, cocamide DEA, FD&C yellow #5, FD&C red #4, fragrance, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water, ricinoleamidopropyl trimethyl ammonium chloride

Questions Or Comments? (Questions or comments?)

call 1-800-581-2528, 24 hours a day, 7 days a week

When Using This 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
do not use routinely if you have wounds which involve more than the superficial layers of the skin

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.

Healthcare Personnel Handwash: (Healthcare personnel handwash:)

wet hands with water
dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds
rinse and dry thoroughly

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 Principal Display Panel (Package/Label Principal Display Panel)

Dr. Dean

Chlorhexidine Gluconate

Solution

0.75%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamedicalsupply.com

4 fl oz (118 mL)

NDC 81657-001-01

MADE IN THE USA

FDA APPROVED

California Prop 65 WARNING

Keep from freezing.

Dr. Dean

Chlorhexidine Gluconate

Solution

0.75%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamedicalsupply.com

8 fl oz (236 mL)

NDC 81657-001-02

MADE IN THE USA

FDA APPROVED

California Prop 65 WARNING

Keep from freezing.

Dr. Dean

Chlorhexidine Gluconate

Solution

0.75%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamedicalsupply.com

8 fl oz (236 mL)

NDC 81657-001-04

MADE IN THE USA

FDA APPROVED

California Prop 65 WARNING

Keep from freezing.

Dr. Dean

Chlorhexidine Gluconate

Solution

0.75%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamedicalsupply.com

128 fl oz (3785 mL)

NDC 81657-001-03

MADE IN THE USA

FDA APPROVED

California Prop 65 WARNING

Keep from freezing.

Advanced Ingredient Data

[{"name": "COCO DIETHANOLAMIDE", "unii": "92005F972D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE (140 CPS AT 5%)", "unii": "8136Y38GY5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURAMINE OXIDE", "unii": "4F6FC4MI8W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "RICINOLEAMIDOPROPYLTRIMONIUM CHLORIDE", "unii": "93OU7D1C3U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 4", "unii": "X3W0AM1JLX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORHEXIDINE", "unii": "R4KO0DY52L", "classCode": "ACTIB", "strengthNumerator": "0.75", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "healthcare personnel handwash: helps reduce bacteria that potentially can cause disease", "60561-8": "Keep from freezing.", "Purpose": "Antiseptic", "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.", "Directions": "use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.", "Do not use": "if you are allergic to chlorhexidine gluconate or any other ingredient in this product", "Active ingredient": "Chlorhexidine gluconate solution, 0.75%", "Other information": "store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)", "Inactive ingredients": "citric acid, cocamide DEA, FD&C yellow #5, FD&C red #4, fragrance, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water, ricinoleamidopropyl trimethyl ammonium chloride", "Questions or comments?": "call 1-800-581-2528 , 24 hours a day, 7 days a week", "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 do not use routinely if you have wounds which involve more than the superficial layers of the skin", "Stop use and ask a doctor if": "irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.", "Healthcare personnel handwash:": "wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds rinse and dry thoroughly", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Package/Label Principal Display Panel": "Dr. Dean Chlorhexidine Gluconate Solution 0.75% Up to 6 Hour Protection Antimicrobial Skin Soap FOR EXTERNAL USE ONLY Distributed by USA Medical Supply Northbrook, IL 60062 www.usamedicalsupply.com 4 fl oz (118 mL) NDC 81657-001-01 MADE IN THE USA FDA APPROVED California Prop 65 WARNING Keep from freezing. Dr. Dean Chlorhexidine Gluconate Solution 0.75% Up to 6 Hour Protection Antimicrobial Skin Soap FOR EXTERNAL USE ONLY Distributed by USA Medical Supply Northbrook, IL 60062 www.usamedicalsupply.com 8 fl oz (236 mL) NDC 81657-001-02 MADE IN THE USA FDA APPROVED California Prop 65 WARNING Keep from freezing. Dr. Dean Chlorhexidine Gluconate Solution 0.75% Up to 6 Hour Protection Antimicrobial Skin Soap FOR EXTERNAL USE ONLY Distributed by USA Medical Supply Northbrook, IL 60062 www.usamedicalsupply.com 8 fl oz (236 mL) NDC 81657-001-04 MADE IN THE USA FDA APPROVED California Prop 65 WARNING Keep from freezing. Dr. Dean Chlorhexidine Gluconate Solution 0.75% Up to 6 Hour Protection Antimicrobial Skin Soap FOR EXTERNAL USE ONLY Distributed by USA Medical Supply Northbrook, IL 60062 www.usamedicalsupply.com 128 fl oz (3785 mL) NDC 81657-001-03 MADE IN THE USA FDA APPROVED California Prop 65 WARNING Keep from freezing."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information