Label: OROXID FORTE ORAL HYGIENE- hydrogen peroxide spray
OROXID FORTE ORAL HYGIENE- hydrogen peroxide solution
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NDC Code(s):
81794-800-30,
81794-800-40,
81794-900-30,
81794-900-50, view more81794-900-60, 81794-900-70
- Packager: Innova Medical Group
- 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 July 12, 2021
If you are a consumer or patient please visit this version.
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- Keep out of reach of children
- Storage and Handling
- Warning
- Innovative Help With
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How to use
Use OROXID Forte two to three times a day prederably during or after brushing your teech. Spray the solution into the oral cavity with 3 to 4 pressures of the spray, gargle for about 30 seconds and spit it out. Use OROXID forte reqularly, until the situation of elimincation of inflammation immproves.
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- Active Ingredient
- Inactive ingredient
- Indication and usage
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INGREDIENTS AND APPEARANCE
OROXID FORTE ORAL HYGIENE
hydrogen peroxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81794-800 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 2.94 mL in 2.94 mL Inactive Ingredients Ingredient Name Strength COMMIPHORA MYRRHA STEM BARK (UNII: I4FHO0W8V5) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) GINGER (UNII: C5529G5JPQ) ECHINACEA PURPUREA (UNII: QI7G114Y98) STEVIA EUPATORIA WHOLE (UNII: D0Y0869IHX) SPEARMINT (UNII: J7I2T6IV1N) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81794-800-30 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/21/2021 2 NDC:81794-800-40 50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/21/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/21/2021 OROXID FORTE ORAL HYGIENE
hydrogen peroxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81794-900 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 2.94 mL in 2.94 mL Inactive Ingredients Ingredient Name Strength COMMIPHORA MYRRHA STEM BARK (UNII: I4FHO0W8V5) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) GINGER (UNII: C5529G5JPQ) ECHINACEA PURPUREA (UNII: QI7G114Y98) STEVIA EUPATORIA WHOLE (UNII: D0Y0869IHX) SPEARMINT (UNII: J7I2T6IV1N) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81794-900-70 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/21/2021 2 NDC:81794-900-60 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/21/2021 3 NDC:81794-900-50 150 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/21/2021 4 NDC:81794-900-30 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/21/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/21/2021 Labeler - Innova Medical Group (117663689) Establishment Name Address ID/FEI Business Operations Innova Medical Group 117663689 label(81794-800, 81794-900) Establishment Name Address ID/FEI Business Operations ENIKAM d.o.o. 520197715 manufacture(81794-800, 81794-900)
