Skin Antisepsis, Oral Cleansing And Nasal Antisepsis System
FDA Label NDC 53462-009

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sage Products, Llc for the product Skin Antisepsis, Oral Cleansing And Nasal Antisepsis System (NDC 53462-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, drugs facts, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Uses

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Drugs Facts

→ Other Information

→ Questions Or Comments?

→ 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.

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.

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.

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.

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.

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

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