FDA Label for Skin Antisepsis, Oral Cleansing And Nasal Antisepsis System
View Indications, Usage & Precautions
Skin Antisepsis, Oral Cleansing And Nasal Antisepsis System Product Label
The following document was submitted to the FDA by the labeler of this product Sage Products, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
- helps reduce bacteria that can potentially cause skin infection
- for preparation of skin prior to surgery
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.
- 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
- 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.
For external use only
Do not use
When using this product
Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.
Otc - 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.
Keep out of reach of children
If 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.
- 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
To open package
Or
Inactive Ingredients
Water, glycerin, xylitol, spearmint flavor, potassium sorbate, polysorbate 20, polysorbate 80, hydroxyethylcellulose, citric acid, sodium saccharin, menthol.
aloe vera, dimethicone, fragrance, glucono-delta-lactone, glycerin, Igepal®, polysorbate 20, propylene glycol, USP purified water
cloth: polyester
Drugs Facts
| Active Ingredient | Purpose |
| Chlorhexidine gluconate 2% solution | Antiseptic |
Other Information
- store product flat
- store between 20-25°C (68-77°F)
- avoid excessive heat above 40°C (104°F)
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
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