MEDLINE PEROXI FRESH MOUTHWASH- hydrogen peroxide mouthwash 
Medline Industries, LP

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.

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086 Medline Peroxi Fresh

Active ingredient

Hydrogen Peroxide 1.5%

Purpose

Oral Debriding Agent

Use

Warnings


Do not use this product

  • for more than 7 days unless directed by a dentist or physician.

When using this product

  • do not swallow

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

Keep out of reach of children

  • If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center right away.

Directions

Other information

Inactive ingredients

flavor, sodium lauryl sulfate, sodium saccharin, water

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: MDS096065HP

V1 RB22ANO

Package Label

PDP

MEDLINE PEROXI FRESH  MOUTHWASH
hydrogen peroxide mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-086
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-086-1359 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/200712/31/2017
2NDC:53329-086-6610 mL in 1 PACKET; Type 0: Not a Combination Product01/01/200707/31/2021
3NDC:53329-086-1459 mL in 1 BOTTLE; Type 0: Not a Combination Product03/08/2017
4NDC:53329-086-957 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/2007
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 3/2022
Document Id: da305d7c-8182-78e2-e053-2995a90a011d
Set id: ec7a9240-6c66-4471-b8b6-776e08a14fbc
Version: 10
Effective Time: 20220314
 
Medline Industries, LP