Label: MEDLINE PEROXI FRESH MOUTHWASH- hydrogen peroxide mouthwash
- NDC Code(s): 53329-086-13, 53329-086-14, 53329-086-66, 53329-086-95
- Packager: Medline Industries, LP
- 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 March 14, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- Adults and Children 2 Years of Age or Over: Swish around in mouth over 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 a doctor.
- Other information
- Inactive ingredients
- Manufacturing Information
- Package Label
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INGREDIENTS AND APPEARANCE
MEDLINE PEROXI FRESH MOUTHWASH
hydrogen peroxide mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-086 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM LAURYL SULFATE (UNII: 368GB5141J) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-086-13 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2007 12/31/2017 2 NDC:53329-086-66 10 mL in 1 PACKET; Type 0: Not a Combination Product 01/01/2007 07/31/2021 3 NDC:53329-086-14 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/08/2017 4 NDC:53329-086-95 7 mL in 1 PACKET; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/01/2007 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)