Label: OROXID SENSITIV- hydrogen peroxide solution
OROXID SENSITIV- hydrogen peroxide spray
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NDC Code(s):
81794-600-30,
81794-600-50,
81794-600-60,
81794-600-70, view more81794-700-30, 81794-700-40
- 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 24, 2021
If you are a consumer or patient please visit this version.
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- Instruction For use
- OTC Active Ingredient
- Storage and handling
- Description
- Inactive Ingredient
- Storage
- Dosage and administration
- Warning
- Indicationg
- Keep reach of Children
- Purpose
- Package
- Package Label
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INGREDIENTS AND APPEARANCE
OROXID SENSITIV
hydrogen peroxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81794-600 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 1.5 mL in 1.5 mL Inactive Ingredients Ingredient Name Strength GINGER (UNII: C5529G5JPQ) ECHINACEA PURPUREA WHOLE (UNII: QI7G114Y98) COMMIPHORA MYRRHA STEM BARK (UNII: I4FHO0W8V5) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) SPEARMINT (UNII: J7I2T6IV1N) WATER (UNII: 059QF0KO0R) STEVIA EUPATORIA WHOLE (UNII: D0Y0869IHX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81794-600-70 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/12/2021 2 NDC:81794-600-50 150 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/12/2021 3 NDC:81794-600-30 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/12/2021 4 NDC:81794-600-60 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/12/2021 OROXID SENSITIV
hydrogen peroxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81794-700 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 1.5 mL in 1.5 mL Inactive Ingredients Ingredient Name Strength SPEARMINT (UNII: J7I2T6IV1N) GINGER (UNII: C5529G5JPQ) WATER (UNII: 059QF0KO0R) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) ECHINACEA PURPUREA WHOLE (UNII: QI7G114Y98) COMMIPHORA MYRRHA STEM BARK (UNII: I4FHO0W8V5) STEVIA EUPATORIA WHOLE (UNII: D0Y0869IHX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81794-700-30 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/12/2021 2 NDC:81794-700-40 50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/12/2021 Labeler - Innova Medical Group (117663689) Establishment Name Address ID/FEI Business Operations Innova Medical Group 117663689 label(81794-600, 81794-700) Establishment Name Address ID/FEI Business Operations ENIKAM d.o.o. 520197715 manufacture(81794-600, 81794-700)
