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

Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System by

Drug Labeling and Warnings

Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System by is a Otc medication manufactured, distributed, or labeled by Sage Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

• Active Ingredient: Purpose
• 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

• Active Ingredient: Purpose
• Chlorhexidine gluconate 2% solution: Antiseptic

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

INGREDIENTS AND APPEARANCE

SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM 
chlorhexidine gluconate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-009

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-009-24	1 in 1 KIT; Type 0: Not a Combination Product	12/28/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKAGE	6
Part 2		1
Part 3	1 PACKET	7 mL

Part 1 of 3

CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate cloth

Product 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 3

SODIUM BICARBONATE 
other oral hygiene products

Product 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 3 of 3

CORINZ 
cetylpyridinium chloride rinse

Product 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	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	01/20/2015

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(53462-009, 53462-705, 53462-375)