Label: Q2 ORAL CARE KIT- hydrogen peroxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 69697-983-01 - Packager: Halyard Health
- Category: HUMAN OTC DRUG LABEL
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 25, 2016
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- Active Ingredient
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- Inactive Ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
Q2 ORAL CARE KIT
hydrogen peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69697-983 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69697-983-01 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 10 TUBE 100 g Part 2 4 CUP, UNIT-DOSE 56 mL Part 3 6 CUP, UNIT-DOSE 84 mL Part 1 of 3 MOUTH MOISTURIZER
other oral hygiene products salveProduct Information Route of Administration ORAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR Xylitol (UNII: VCQ006KQ1E) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR Aloe Vera Flower (UNII: 575DY8C1ER) INGR Propylene Glycol (UNII: 6DC9Q167V3) INGR Potassium Sorbate (UNII: 1VPU26JZZ4) INGR Sorbitol (UNII: 506T60A25R) INGR Hydroxypropyl Cellulose (Type H) (UNII: RFW2ET671P) INGR Dimethicone (UNII: 92RU3N3Y1O) INGR Potassium Chloride (UNII: 660YQ98I10) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 g in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 06/25/2008 Part 2 of 3 HYDROGEN PEROXIDE
hydrogen peroxide mouthwashProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrogen peroxide (UNII: BBX060AN9V) (Hydrogen peroxide - UNII:BBX060AN9V) Hydrogen peroxide 0.015 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Mint (UNII: FV98Z8GITP) Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 14 mL in 1 CUP, UNIT-DOSE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 08/26/2008 Part 3 of 3 ALCOHOL FREE
mouthwashes and breath fresheners (liquids and sprays) mouthwashProduct Information Route of Administration ORAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR Benzoic Acid (UNII: 8SKN0B0MIM) INGR Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR Glycerin (UNII: PDC6A3C0OX) INGR Cetylpyridinium Chloride (UNII: D9OM4SK49P) INGR D&C Green No. 5 (UNII: 8J6RDU8L9X) INGR Sorbitol (UNII: 506T60A25R) INGR Mint (UNII: FV98Z8GITP) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 14 mL in 1 CUP, UNIT-DOSE ; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 03/13/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/26/2008 Labeler - Halyard Health (079617666) Establishment Name Address ID/FEI Business Operations Avent 049316284 MANUFACTURE(69697-983) Establishment Name Address ID/FEI Business Operations Elba 108428483 MANUFACTURE(69697-983) Establishment Name Address ID/FEI Business Operations Hi Tech Pharmacal 101196749 MANUFACTURE(69697-983)