Chlorhexidine Gluconate 2% Solution

Chlorhexidine Gluconate 2% Solution
SPL v21
SPL
SPL Set ID bdb6a012-37e5-4664-84a3-134bea284744
Route
TOPICAL
Published
Effective Date 2024-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (500 mg)
Inactive Ingredients
Water Nonoxynol-9 Polysorbate 20 Dimethicone 350 Propylene Glycol Aloe Vera Leaf Glycerin Gluconolactone

Identifiers & Packaging

Marketing Status
NDA Active Since 2006-02-01 Until 2024-04-01

Description

 Active Ingredient  Purpose Chlorhexidine Gluconate 2% Solution     Antiseptic


Medication Information

Description

 Active Ingredient  Purpose Chlorhexidine Gluconate 2% Solution     Antiseptic

Uses
  • helps reduce bacteria that can potentially cause skin infection
  • for preparation of skin prior to surgery

2 Pack

6 Pack

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.

Do not use

  • on patients allergic to chlorhexidine gluconate or any other ingredient in this product
  • for lumbar punctures or in contact with the meninges
  • on open skin wounds or as a general skin cleanser

When using this product

  • keep out of eyes, ears and mouth.  May cause serious or permanent injury if chlorhexidine is permitted to enter and remain.  If contact occurs, rinse with cold water right away and contact a doctor.

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs.  These may be signs of a serious condition.

Directions
  • use with care in premature infants or infants under 2 months of age.  These products may cause irritation or chemical burns.
  • do not microwave
  • product and packaging are not sterile.  Follow your hospital policy for skin preparation with non-sterile products.

To open package

  • holding top of package in one hand, lift flap on backside of package with other hand
  • grasp flap at top and pull down to tear flap away and expose foam
  • hold outside of package to present foam and cloths to prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination

Or

  • using sterile scissors, cut off end seal of package
  • transfer contents onto prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination
  • use first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated.  Use second cloth to prepare larger areas.
  • dry surgical sites (such as abdomen or arm):  use one cloth to cleanse each 161 cm 2 area (approximately 5 x 5 inches) of skin to be prepared.  Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.  Allow area to air dry for one (1) minute.  Do not rinse.
  • moist surgical sites (such as inguinal fold):  use one cloth to cleanse each 65 cm 2 area (approximately 2 x 5 inches) of skin to be prepared.  Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.  Allow area to air dry for one (1) minute.  Do not rinse.
  • discard each cloth after a single use
  • after package has been opened discard any unused cloths
Other Information

store product flat

store between 20-25°C (68-77°F)

avoid excessive heat above 40°C (104°F)

Questions Or Comments?

call toll-free 800-323-2220

(Monday to Friday 8 AM - 5 PM CST)

www.sageproducts.com

DO NOT FLUSH CLOTHS

Not made with natural rubber latex

Patents:

www.sageproducts.com/patents

inactive Ingredients

aloe vera, dimethicone, fragrance, glucono-delta-lactone, glycerin, nonoxynol-9, polysorbate 20, propylene glycol, USP purified water

cloth:  polyester

Keep Out of Reach of Children

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

2% Chlorhexidine Gluconate Cloth
 Active Ingredient  Purpose
Chlorhexidine Gluconate 2% Solution     Antiseptic


Structured Label Content

Uses
  • helps reduce bacteria that can potentially cause skin infection
  • for preparation of skin prior to surgery

2 Pack (2 pack)

6 Pack (6 pack)

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.

Do not use

  • on patients allergic to chlorhexidine gluconate or any other ingredient in this product
  • for lumbar punctures or in contact with the meninges
  • on open skin wounds or as a general skin cleanser

When using this product

  • keep out of eyes, ears and mouth.  May cause serious or permanent injury if chlorhexidine is permitted to enter and remain.  If contact occurs, rinse with cold water right away and contact a doctor.

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs.  These may be signs of a serious condition.

Directions
  • use with care in premature infants or infants under 2 months of age.  These products may cause irritation or chemical burns.
  • do not microwave
  • product and packaging are not sterile.  Follow your hospital policy for skin preparation with non-sterile products.

To open package

  • holding top of package in one hand, lift flap on backside of package with other hand
  • grasp flap at top and pull down to tear flap away and expose foam
  • hold outside of package to present foam and cloths to prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination

Or

  • using sterile scissors, cut off end seal of package
  • transfer contents onto prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination
  • use first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated.  Use second cloth to prepare larger areas.
  • dry surgical sites (such as abdomen or arm):  use one cloth to cleanse each 161 cm 2 area (approximately 5 x 5 inches) of skin to be prepared.  Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.  Allow area to air dry for one (1) minute.  Do not rinse.
  • moist surgical sites (such as inguinal fold):  use one cloth to cleanse each 65 cm 2 area (approximately 2 x 5 inches) of skin to be prepared.  Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.  Allow area to air dry for one (1) minute.  Do not rinse.
  • discard each cloth after a single use
  • after package has been opened discard any unused cloths
Other Information (Other information)

store product flat

store between 20-25°C (68-77°F)

avoid excessive heat above 40°C (104°F)

Questions Or Comments? (Questions or comments?)

call toll-free 800-323-2220

(Monday to Friday 8 AM - 5 PM CST)

www.sageproducts.com

DO NOT FLUSH CLOTHS

Not made with natural rubber latex

Patents:

www.sageproducts.com/patents

inactive Ingredients (Inactive Ingredients)

aloe vera, dimethicone, fragrance, glucono-delta-lactone, glycerin, nonoxynol-9, polysorbate 20, propylene glycol, USP purified water

cloth:  polyester

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.

2% Chlorhexidine Gluconate Cloth (2% CHLORHEXIDINE GLUCONATE CLOTH)
 Active Ingredient  Purpose
Chlorhexidine Gluconate 2% Solution     Antiseptic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)