Label: HYDROGEN PEROXIDE solution
- NDC Code(s): 46994-871-43
- Packager: Moran Foods, LLC
- 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 31, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
First aid antiseptic:
- clean the affected area
- apply a small amound of product on the affected area 1 to 3 times a day
- may be covered with a sterile bandage
- if bandaged, let dry first
Oral debriding agent: adults, children over 2 years of age:
- mix with equal amount of water
- swish aroud in the mouth over the affected area for at least 1 minute, then spit out
- use up to 4 times daily after meals and at bedtime
- children under 12 years of age should be supervised in the use.
- children under 2 years of age: consult a dentist, doctor
- Other information
- Inactive ingredient
- SPL UNCLASSIFIED SECTION
- Principal display panel
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INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE
hydrogen peroxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46994-871 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46994-871-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1989 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/15/1989 Labeler - Moran Foods, LLC (095484572) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(46994-871) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(46994-871)
