Label: SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM- chlorhexidine gluconate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 17518-060-04, 53462-110-29, 53462-375-60, 53462-705-23 - Packager: Sage Products, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated February 7, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Before opening, turn package over, burst solution packet with thumbs.
- Peel lid to open.
- Brush teeth and oral cavity for approximately one minute.
- Instruct to expectorate.
- Use Applicator Swab for additional cleansing as needed.
- Discard after use.
- Use up to 4 times daily or as directed by a dentist or doctor.
- Children under 12 yeras of age: supervise use.
- Children under 3 years of age: consult a dentist or doctor.
- Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
- Ensure foam is intact after use. If not, remove any particles from oral cavity.
- DOSAGE & ADMINISTRATION
- Inactive Ingredients
- Drugs Facts
- Uses
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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
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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
- Other information
- Inactive Ingredients
- Questions or comments?
- Nose to Toes: Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System
- 3M Skin and Nasal Antiseptic
-
INGREDIENTS AND APPEARANCE
SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM
chlorhexidine gluconate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53462-110 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53462-110-29 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 12/28/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKAGE 6 Part 2 1 PACKET 7 mL Part 3 1 Part 4 1 BOTTLE 4 mL Part 1 of 4 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 6 in 1 KIT 1 NDC:53462-705-23 6 in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021669 02/01/2006 Part 2 of 4 CORINZ
cetylpyridinium chloride rinseProduct Information Item Code (Source) NDC:53462-375 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) XYLITOL (UNII: VCQ006KQ1E) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYSORBATE 20 (UNII: 7T1F30V5YH) POLYSORBATE 80 (UNII: 6OZP39ZG8H) HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SACCHARIN SODIUM (UNII: SB8ZUX40TY) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53462-375-60 1 in 1 KIT 1 7 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/20/2016 Part 3 of 4 SODIUM BICARBONATE
other oral hygiene productsProduct Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR SODIUM BICARBONATE (UNII: 8MDF5V39QO) INGR CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) INGR SODIUM LAURYL SULFATE (UNII: 368GB5141J) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR WATER (UNII: 059QF0KO0R) INGR SACCHARIN SODIUM (UNII: SB8ZUX40TY) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 4 of 4 3M SKIN AND NASAL ANTISEPTIC
povidone-iodine 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) 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) STEARETH-100 (UNII: 4OH5W9UM87) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 KIT 1 NDC:17518-060-04 4 mL in 1 BOTTLE; Type 0: Not a Combination Product 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 12/28/2016 Labeler - Sage Products, LLC (054326178) Registrant - Sage Products, LLC (054326178) Establishment Name Address ID/FEI Business Operations Sage Products, LLC 054326178 manufacture(53462-110, 53462-705, 53462-375) Establishment Name Address ID/FEI Business Operations 3M Health Care LTD 218829455 manufacture(17518-060)