Label: SHORT TERM ORAL CARE SYSTEM- hydrogen peroxide kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 17, 2019

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  • Drug Facts

    Active Ingredients for 6065

  • Use

    Aids in the removal of secretions associated with sore mouth

  • INDICATIONS & USAGE

  • 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

    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

    • 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

  • SPL UNCLASSIFIED SECTION

    MADE IN U.S.A.

    NOT MADE WITH NATURAL RUBBER LATEX

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

    Short term kit 6002Dperoxamint 6065

  • INGREDIENTS AND APPEARANCE
    SHORT TERM ORAL CARE SYSTEM 
    hydrogen peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-024
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-024-301 in 1 KIT; Type 1: Convenience Kit of Co-Package10/19/2016
    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 
    other oral hygiene products
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    INGRSODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 KIT
    19 g in 1 TUBE; Type 0: Not a Combination Product
    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 AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 KIT
    1NDC:53462-075-3044 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/21/1998
    Part 3 of 3
    MOUTH MOISTURIZER 
    other oral hygiene products
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
    INGRXYLITOL (UNII: VCQ006KQ1E)  
    INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRCETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    INGRCARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    INGRSPEARMINT OIL (UNII: C3M81465G5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 KIT
    114 g in 1 TUBE; Type 0: Not a Combination Product
    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/FEIBusiness Operations
    Sage Products LLC054326178manufacture(53462-024, 53462-075)
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