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Short Term Oral Care System

Medically reviewed on January 30, 2017

Dosage form: kit
Ingredients: ; HYDROGEN PEROXIDE 15mg in 1mL
Labeler: Sage Products LLC
NDC Code: 53462-024

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.

Short Term Oral Care System

Drug Facts

Use

Aids in the removal of secretions associated with sore mouth

Warnings

Do not use:

  • For more than 7 days unless told to do so by a doctor.
  • Avoid Swallowing.

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
  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp. Instruct to expectorate.
  • Children under 12 yeras of age: supervise use.
  • Children under 3 years of age: consult a dentist or doctor.

Inactive Ingredients

Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI42090), Yellow 6 (CI15985)

Questions

Call toll free 800-323-2220

MADE IN U.S.A.

NOT MADE WITH NATURAL RUBBER LATEX

Short Term Oral Care System with Perox-A-Mint Solution

Established Pharmacological Class
SubstancePharmacological Class
Sodium BicarbonateOther Oral Hygiene Products
Mouth MoisturizerOther Oral Hygiene Products
SHORT TERM ORAL CARE SYSTEM 
hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-024
Packaging
#Item CodePackage Description
1NDC:53462-024-301 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 9 g
Part 21 BOTTLE, PLASTIC 44 mL
Part 31 TUBE 14 g
Part 1 of 3
SODIUM BICARBONATE 
Product Information
Ingredients
Ingredient NameQuantity
SODIUM BICARBONATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM LAURYL SULFATE 
SODIUM BENZOATE 
WATER 
SACCHARIN SODIUM 
Packaging
#Item CodePackage Description
11 TUBE in 1 KIT
19 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 2 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 
PHOSPHORIC ACID 
POLYSORBATE 80 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
Packaging
#Item CodePackage Description
11 BOTTLE, PLASTIC in 1 KIT
1NDC:53462-075-3044 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Part 3 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 TUBE in 1 KIT
114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/19/2016
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)
Establishment
NameAddressID/FEIOperations
Sage Products LLC054326178manufacture(53462-024, 53462-075)

 
Sage Products LLC

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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