Sunmart 8-oz

Sunmart 8-oz
SPL v5
SPL
SPL Set ID 1223185b-c94c-5a9a-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
NDA Active Since 2014-02-20

Description

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine Gluconate 4% Solution

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

Section 51945-4

sunmark

Compare to the active ingredient in Hibiclens®

NDC 49348-115-37

antiseptic skin cleanser

Chlorhexidine Gluconate 4% Solution

Antiseptic/Antimicrobial

Skin Cleanser

Dye free

FOR EXTERNAL USE ONLY

NET CONTENTS: 8 fl oz (237 mL)

Section 60561-8

Warning: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer.

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use non-chlorine detergents.

*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.

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 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 5ml of product into cupped hands and wahs in 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 are allergic to chlorhexidine gluconate or any other ingredient
  • in contact with meninges
  • in genital area
Other Information
  • store at 20°-25° C (68°-77° F)
  • avoid excessive heat above 40° C (104° F)
Active Ingredients

Chlorhexidine Gluconate 4% Solution

Inactive Ingredients

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

Questions of Comments?

call 1-800-587-3721 Monday through Friday 8 AM to 4:30 PM CST

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 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


Structured Label Content

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

Section 51945-4 (51945-4)

sunmark

Compare to the active ingredient in Hibiclens®

NDC 49348-115-37

antiseptic skin cleanser

Chlorhexidine Gluconate 4% Solution

Antiseptic/Antimicrobial

Skin Cleanser

Dye free

FOR EXTERNAL USE ONLY

NET CONTENTS: 8 fl oz (237 mL)

Section 60561-8 (60561-8)

Warning: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer.

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use non-chlorine detergents.

*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.

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 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 5ml of product into cupped hands and wahs in 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 are allergic to chlorhexidine gluconate or any other ingredient
  • in contact with meninges
  • in genital area
Other Information (Other information)
  • store at 20°-25° C (68°-77° F)
  • avoid excessive heat above 40° C (104° F)
Active Ingredients

Chlorhexidine Gluconate 4% Solution

Inactive Ingredients (Inactive ingredients)

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

Questions of Comments? (Questions of comments?)

call 1-800-587-3721 Monday through Friday 8 AM to 4:30 PM CST

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
  • 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 Doctor If (Stop use and ask 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


Advanced Ingredient Data


Raw Label Data

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