Label: SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM- chlorhexidine gluconate kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 24, 2019

If you are a consumer or patient please visit this version.

  • Drug Facts

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

  • INDICATIONS & USAGE

    Use

    Helps reduce 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

    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.
  • DOSAGE & ADMINISTRATION

  • 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

    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

    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

  • PRINCIPAL DISPLAY PANEL

    9009 LabelCorinz PacketCorinz Drug Facts9707 Primary Package Label

  • INGREDIENTS AND APPEARANCE
    SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM 
    chlorhexidine gluconate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-009
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-009-241 in 1 KIT; Type 0: Not a Combination Product12/28/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKAGE
    Part 2
    Part 31 PACKET 7 mL
    Part 1 of 3
    CHLORHEXIDINE GLUCONATE 
    chlorhexidine gluconate cloth
    Product Information
    Item Code (Source)NDC:53462-705
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    16 in 1 KIT
    1NDC:53462-705-236 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02166902/01/2006
    Part 2 of 3
    SODIUM BICARBONATE 
    other oral hygiene products
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    INGRSODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 3 of 3
    CORINZ 
    cetylpyridinium chloride rinse
    Product Information
    Item Code (Source)NDC:53462-375
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-375-607 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/20/2015
    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/FEIBusiness Operations
    Sage Products, LLC054326178manufacture(53462-009, 53462-705, 53462-375)