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Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System

Dosage form: kit
Ingredients: CHLORHEXIDINE GLUCONATE 500mg; CETYLPYRIDINIUM CHLORIDE 0.5mg in 1mL; ; POVIDONE-IODINE 5mg in 1mL
Labeler: Sage Products, LLC
NDC Code: 53462-110

Nose to Toes: Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System

Drug Facts
 Active Ingredient Purpose
 Corinz™ Antiseptic Cleansing and Moisturizing Oral Rinse:
 Cetylpyridinium Chloride 0.05% Antiseptic Rinse

Uses
  • Aids in the removal of dental plaque, debris and secretions and helps reduce the chance of infection in minor oral irritation.

Warnings 

Stop use and ask a doctor if:

  • Sore mouth symptoms do not improve in 7 days.
  • Swelling, rash or fever develops.
  • Irritation, pain or redness persists or worsens.

Keep out of reach of children.

If more than used for antisepsis is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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.

Inactive Ingredients

Water, glycerin, xylitol, spearmint flavor, potassium sorbate, polysorbate 20, polysorbate 80, hydroxyethylcellulose, citric acid, sodium saccharin, menthol.

Drugs Facts
CHG 2%
 Active Ingredient Purpose
 Chlorhexidine gluconate 2% solutionAntiseptic

Uses
  • 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

Other information
  • store product flat
  • store between 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive Ingredients

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

DO NOT FLUSH CLOTHS. Not made with Natural Rubber Latex. 

Patents:

www.sageproducts.com/patents

Nose to Toes: Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System 

3M Skin and Nasal Antiseptic

Established Pharmacological Class
SubstancePharmacological Class
Sodium BicarbonateOther Oral Hygiene Products
SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM 
chlorhexidine gluconate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-110
Packaging
#Item CodePackage Description
1NDC:53462-110-291 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKAGE
Part 21 PACKET 7 mL
Part 3
Part 41 BOTTLE 4 mL
Part 1 of 4
CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate cloth
Product Information
Item 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 Description
16 PACKAGE in 1 KIT
1NDC:53462-705-236 CLOTH in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02166902/01/2006
Part 2 of 4
CORINZ 
cetylpyridinium chloride rinse
Product Information
Item Code (Source)NDC:53462-375
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
XYLITOL 
POTASSIUM SORBATE 
POLYSORBATE 20 
POLYSORBATE 80 
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) 
CITRIC ACID MONOHYDRATE 
SACCHARIN SODIUM 
MENTHOL, UNSPECIFIED FORM 
Packaging
#Item CodePackage Description
1NDC:53462-375-601 PACKET in 1 KIT
17 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/20/2016
Part 3 of 4
SODIUM BICARBONATE 
Product Information
Ingredients
Ingredient NameQuantity
SODIUM BICARBONATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM LAURYL SULFATE 
SODIUM BENZOATE 
WATER 
SACCHARIN SODIUM 
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 4 of 4
3M SKIN AND NASAL ANTISEPTIC 
povidone-iodine solution
Product Information
Item Code (Source)NDC:17518-060
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LACTIC ACID 
LAURAMIDOPROPYLAMINE OXIDE 
MALIC ACID 
SODIUM HYDROXIDE 
SODIUM IODIDE 
STEARETH-100 
WATER 
XYLITOL 
Packaging
#Item CodePackage Description
11 BOTTLE in 1 KIT
1NDC:17518-060-044 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/01/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02166912/28/2016
Labeler - Sage Products, LLC (054326178)
Registrant - Sage Products, LLC (054326178)
Establishment
NameAddressID/FEIOperations
Sage Products, LLC054326178manufacture(53462-110, 53462-705, 53462-375)
Establishment
NameAddressID/FEIOperations
3M Health Care LTD218829455manufacture(17518-060)

 
Sage Products, LLC

← See all Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System brands

Medically reviewed on Feb 7, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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