CHLORHEXIDINE GLUCONATE cloth

CHLORHEXIDINE GLUCONATE by

Drug Labeling and Warnings

CHLORHEXIDINE GLUCONATE by is a Otc medication manufactured, distributed, or labeled by Sage Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredient: Purpose
• Chlorhexidine Gluconate 2% Solution: Antiseptic

PURPOSE

Uses

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

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.

Keep out of reach of children

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

Keep out of reach of children

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

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)

INACTIVE INGREDIENT

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

cloth:  polyester

Questions or comments?

call toll-free 800-323-2220

(Monday to Friday 8 AM - 5 PM CST)

www.sageproducts.com

Chlorhexidine Gluconate 2% Solution - 9705

Chlorhexidine Gluconate 2% Solution - 9707

INGREDIENTS AND APPEARANCE

CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-705
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	500 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NONOXYNOL-9 (UNII: 48Q180SH9T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
GLUCONOLACTONE (UNII: WQ29KQ9POT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-705-20	2 in 1 PACKAGE; Type 0: Not a Combination Product	02/01/2006
2	NDC: 53462-705-23	6 in 1 PACKAGE; Type 0: Not a Combination Product	02/01/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021669	02/01/2006

Labeler - Sage Products LLC (054326178)

Registrant - Sage Products LLC (054326178)