Label: SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS- chlorhexidine gluconate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 17518-060-04, 53462-008-28, 53462-705-23 - Packager: Sage Products, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 22, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
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WHEN USING
- 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.
Do not use if you have a known sensitivity to iodine or any other ingredient in this product. Do not use in eyes. If product gets into eyes, flush immediately with water. Do not use on infants less than 2 months old due to the risk of increased blood iodine levels.
Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.
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DOSAGE & ADMINISTRATION
2% Chlorhexidine Gluconate Cloth
- 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.
- 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.
- 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
- open package and remove bottle and swabs
- unscrew cap by turning cap counter-clockwise
- Apply to clean dry skin.
- Dip one swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid wiping solution off during removal.
- Scrub prep site for 2 minutes working from clean to dirty using both sides of the swab.
- Repeat steps 2 & 3 using second swab.
- Allow prep solution to dry. Do not blot.
- Use a tissue to clean the inside of both nostrils including the inside tip of nostril. Discard.
- Tilting the bottle slightly, dip one swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid wiping solution off during removal.
- Insert swab comfortably into one nostril and rotate for 15 seconds covering all surfaces. Then focus on the inside tip of nostril and rotate for an additional 15 seconds. (swab 1)
- Using a new swab: Repeat steps 2 & 3 with the other nostril. (swab 2)
- Repeat the application in both nostrils using a fresh swab each time. (swabs 3 & 4)
- Do not blow nose. If solution drips out of nose, it can be lightly dabbed with a tissue.
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INACTIVE INGREDIENT
2% Chlorhexidine Gluconate Cloth
aloe vera, dimethicone, fragrance, glucono-delta-lactone, glycerin, Igepal, polysorbate 20, propylene glycol, USP purified water
cloth: polyester3M Skin and Nasal Antiseptic
Lactic acid, lauramidopropylamine oxide, malic acid, polyquarternium-10, PPG-5-ceteth-10 phosphate, sodium hydroxide, sodium iodide, steareth-100, water, xylitol - PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS
chlorhexidine gluconate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53462-008 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53462-008-28 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKAGE 6 Part 2 1 BOTTLE 4 mL Part 1 of 2 CHLORHEXIDINE GLUCONATE
chlorhexidine gluconate clothProduct Information 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:53462-705-23 6 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021669 02/01/2006 Part 2 of 2 3M SKIN AND NASAL ANTISEPTIC
3m skin and nasal antiseptic solutionProduct Information Item Code (Source) NDC:17518-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) POVIDONE-IODINE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength LACTIC ACID (UNII: 33X04XA5AT) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) MALIC ACID (UNII: 817L1N4CKP) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM IODIDE (UNII: F5WR8N145C) PEG-100 STEARATE (UNII: YD01N1999R) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 POUCH 1 NDC:17518-060-04 4 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021669 02/06/2012 Labeler - Sage Products, Inc. (054326178) Establishment Name Address ID/FEI Business Operations Sage Products, Inc. 054326178 MANUFACTURE(53462-008) Establishment Name Address ID/FEI Business Operations 3M ESPE Dental Products 078404534 MANUFACTURE(17518-060, 53462-705) Establishment Name Address ID/FEI Business Operations 3M Health Care LTD 218829455 MANUFACTURE(17518-060, 53462-705)