Label: ORAL CARE Q4 KIT- hydrogen peroxide kit
-
Contains inactivated NDC Code(s)
NDC Code(s): 69697-986-01 - Packager: Halyard Health
- 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 26, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other Information
- Inactive Ingredients
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other Information
- Inactive Ingredients
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
-
INGREDIENTS AND APPEARANCE
ORAL CARE Q4 KIT
hydrogen peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69697-986 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69697-986-01 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 4 CUP, UNIT-DOSE 56 mL Part 2 2 CUP, UNIT-DOSE 28 mL Part 3 6 TUBE 60 g Part 1 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 2 of 3 CETYLPYRIDINIUM CHLORIDE
cetylpyridinium chloride mouthwashProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3) Cetylpyridinium Chloride 0.0005 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Benzoic Acid (UNII: 8SKN0B0MIM) Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY) Sodium Benzoate (UNII: OJ245FE5EU) Glycerin (UNII: PDC6A3C0OX) D&C Green No. 5 (UNII: 8J6RDU8L9X) Sorbitol (UNII: 506T60A25R) Mint (UNII: FV98Z8GITP) Product Characteristics Color BLUE Score Shape Size Flavor 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 03/13/2008 Part 3 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 03/13/2008 Labeler - Halyard Health (079617666) Establishment Name Address ID/FEI Business Operations Avent 049316284 MANUFACTURE(69697-986) Establishment Name Address ID/FEI Business Operations Elba 108428483 MANUFACTURE(69697-986) Establishment Name Address ID/FEI Business Operations Hi Tech Pharmacal 101196749 MANUFACTURE(69697-986)