Your browser does not support JavaScript! CHLORHEXIDINE GLUCONATE CLOTH [SAGE PRODUCTS INC.]
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CHLORHEXIDINE GLUCONATE cloth
[Sage Products Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

chlorhexidine gluconate 2% solution

Antiseptic

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

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

Warnings

For external use only

Do not use

  • on patients with known allergies to chlorhexidine gluconate or any other ingredients 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.

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 cm2 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 cm2 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

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

cloth:  polyester

image of film R5201E

image of film R5335B

image of prepcheck sticker







CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate cloth
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53462-705
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
chlorhexidine gluconate (chlorhexidine) chlorhexidine gluconate500 mg
Inactive Ingredients
Ingredient NameStrength
water 
nonoxynol-9 
polysorbate 20 
dimethicone 350 
propylene glycol 
aloe vera leaf 
glycerin 
gluconolactone 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-705-202 in 1 PACKAGE
2NDC:53462-705-232 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02166902/01/2006
Labeler - Sage Products Inc. (054326178)
Establishment
NameAddressID/FEIBusiness Operations
Sage Products Inc.054326178manufacture

Revised: 6/2012
 
Sage Products Inc.

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