Label: HYDROGEN PEROXIDE solution
- NDC Code(s): 53942-871-43, 53942-871-45
- Packager: Demoulas Super Markets, Inc
- 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, 2023
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- Active ingredient
- Use
- Warnings
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Directions
First aid antiseptic:
•clean the affected area
•apply a small amount 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 (oral rinse): adults and children 2 years of age and over:
•mix with an equal amount of water
•swish around in the mouth over the affected area for at least 1 minute and then spit out
•use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
•children under 12 years of age should be supervised in the use of this product
•children under 2 years of age: consult a dentist or doctor - Other information
- Inactive ingredient
- SPL UNCLASSIFIED SECTION
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HYDROGEN PEROXIDE
TOPICAL SOLUTION USP
FIRST AID ANTISEPTIC
ORAL DEBRIDING AGENT
Square bottle uses less plastic than a similarly sized round bottle
Recyclable (if available in your area)
Do not use if printed seal under cap is broken or missing
16 FL OZ (1PT) 473 mL
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INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE
hydrogen peroxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53942-871 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53942-871-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1989 2 NDC:53942-871-45 946 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 - Demoulas Super Markets, Inc (007869647) Registrant - Vi Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(53942-871) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 088520668 manufacture(53942-871)