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Suction Toothbrush with Perox-A-Mint Solution

Dosage form: kit
Ingredients: ; HYDROGEN PEROXIDE 15mg in 1mL
Labeler: Sage Products LLC
NDC Code: 53462-971

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

SUCTION TOOTHBRUSH with Perox-A-Mint® Solution

Drug Facts
Suction Swab with Perox-A-Mint Solution
Active Ingredient: 
PEROX-A-MINT:
Purpose
Hydrogen Peroxide 1.5%Oral Debriding Agent

Uses
  • Aids in the removal of debris, dental plaque and secretions.

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.

If more than used for debriding 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.
  • Remove Mouth Moisturizer and Applicator Swab.
  • Attach Suction Toothbrush to Suction Handle.
  • Clean teeth and oral cavity for approximately one minute.
  • To suction, slide switch to ON. When finished, return switch to OFF.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Remove Toothbrush from Suction Handle and discard.
  • Place Mouth Moisturizer on Applicator Swab.
  • Apply as needed to lips and inside mouth.
  • Discard Suction Handle after using for 24 hours, or according to hospital protocol.
  • 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, FD&C Blue No. 1, FD&C Yellow No. 6.

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

SUCTION TOOTHBRUSH with Perox-A-Mint Solution

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Established Pharmacological Class
SubstancePharmacological Class
Mouth MoisturizerOther Oral Hygiene Products
Sodium BicarbonateOther Oral Hygiene Products
SUCTION TOOTHBRUSH WITH PEROX-A-MINT SOLUTION 
hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-971
Packaging
#Item CodePackage Description
1NDC:53462-971-601 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 2 g
Part 2
Part 31 PACKET 7 mL
Part 1 of 3
MOUTH MOISTURIZER 
Product Information
Ingredients
Ingredient NameQuantity
COCONUT OIL 
XYLITOL 
CARBOXYMETHYLCELLULOSE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
POLYSORBATE 20 
POLYSORBATE 80 
POTASSIUM SORBATE 
CETYLPYRIDINIUM CHLORIDE 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
SPEARMINT OIL 
Packaging
#Item CodePackage Description
11 PACKET in 1 KIT
12 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 2 of 3
SODIUM BICARBONATE 
Product Information
Ingredients
Ingredient NameQuantity
SODIUM BICARBONATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM LAURYL SULFATE 
SODIUM BENZOATE 
WATER 
SACCHARIN SODIUM 
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 3 of 3
PEROX-A-MINT SOLUTION 
hydrogen peroxide mouthwash
Product Information
Item Code (Source)NDC:53462-075
Route of AdministrationBUCCALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYSORBATE 80 
PHOSPHORIC ACID 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
Packaging
#Item CodePackage Description
11 PACKET in 1 KIT
17 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/13/2016
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)
Establishment
NameAddressID/FEIOperations
Sage Products LLC054326178manufacture(53462-971, 53462-075)

Revised: 02/2017
 
Sage Products LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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