SUCTION SWABS WITH PEROX-A-MINT SOLUTION- hydrogen peroxide kit

Suction Swabs with Perox-A-Mint Solution by

Drug Labeling and Warnings

Suction Swabs with Perox-A-Mint Solution 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: PEROX-A-MINT: Purpose
• Hydrogen Peroxide 1.5%: Oral Debriding Agent

Uses

• 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 debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer

• Before opening, turn package over, burst solution packet with thumbs.
• Peel lid to open.
• Remove Suction Swab and attach to suction line.
• Clean teeth and oral cavity for approximately 1 minute.
• To suction, place thumb over port.
• Repeat cleaning with other Suction Swab as needed.
• To clear tubing, rinse with sterile saline or appropriate solution.
• 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: 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.

Suction Swabs with Perox-A-Mint solution

• Before opening, turn package over, burst solution packet with thumbs.
• Peel lid to open.
• Remove Suction Swab and attach to suction line.
• Clean teeth and oral cavity for approximately 1 minute.
• To suction, place thumb over port.
• Repeat cleaning with other Suction Swab as needed.
• To clear tubing, rinse with sterile saline or appropriate solution.
• Discard after use.
• Use up to 4 times daily, or as directed by a dentist or doctor.
• Children under 12 years 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.

Inactive Ingredients

Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985).

QUESTIONS

Questions? Call toll-free 800-323-2220.

Suction Swabs with Perox-A-Mint Solution

INGREDIENTS AND APPEARANCE

SUCTION SWABS WITH PEROX-A-MINT SOLUTION 
hydrogen peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-813

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-813-60	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	06/28/2002

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

Part 1 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 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

PEROX-A-MINT SOLUTION 
hydrogen peroxide mouthwash

Product Information
Item Code (Source)	NDC: 53462-075
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 KIT
1		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	05/21/1998

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/28/2002

Labeler - Sage Products LLC (054326178)

Registrant - Sage Products LLC (054326178)

Establishment
Name	Address	ID/FEI	Business Operations
Sage Products LLC		054326178	manufacture(53462-813, 53462-075)