SUCTION SWAB SYSTEM- cetylpyridinium chloride kit

Suction Swab System by

Drug Labeling and Warnings

Suction Swab 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 .05%: Oral Antiseptic

Uses

• Helps reduce the chance of infection in minor oral irritation.
• Aids in the removal of debris and secretions.

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

Directions

• Before opening, turn package over, burst solution packet with thumbs.
• Peel lid to open. 
• Remove swab and attach to suction line.  
• Clean teeth and oral cavity for approximately one minute.
• To suction, place thumb over port.
• Repeat cleaning with other swab as needed.
• Discard after use.
• Apply Mouth Moisturizer as needed.
• Use up to 4 times daily, or as directed by a dentist or doctor.
• Children under 12 years of age should be supervised in the use of this product.
• 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, sorbitol, peppermint flavor, potssium sorbate, polysorbate 80, polysorbate 20, citric acid, FD&C Blue #1.

Questions

Call toll free 800-323-2220

SPL UNCLASSIFIED SECTION

MADE IN U.S.A.

NOT MADE WITH NATURAL RUBBER LATEX

Suction Swab System with Antiseptic Oral Rinse and Mouth Moisturizer

Suction Swab System Reorder No. 6115

NDC: 53462-215-60

Antiseptic Oral Rinse Packet

NDC: 53462-175-60

INGREDIENTS AND APPEARANCE

SUCTION SWAB SYSTEM 
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-215

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-215-60	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	12/30/2006

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

Part 1 of 3

ANTISEPTIC ORAL RINSE 
cetylpyridinium chloride mouthwash

Product Information
Item Code (Source)	NDC: 53462-175
Route of Administration	BUCCAL

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)
SORBITOL (UNII: 506T60A25R)
PEPPERMINT (UNII: V95R5KMY2B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 KIT
1	NDC: 53462-175-60	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	06/21/2000

Part 2 of 3

MOUTH MOISTURIZER 
other oral hygiene products

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	XYLITOL (UNII: VCQ006KQ1E)
INGR	CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	WATER (UNII: 059QF0KO0R)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	POLYSORBATE 80 (UNII: 6OZP39ZG8H)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
INGR	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
INGR	SPEARMINT OIL (UNII: C3M81465G5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 KIT
1		2 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 3 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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/30/2006

Labeler - Sage Products LLC (054326178)

Registrant - Sage Products LLC (054326178)