MEDPAK PEROXIDE ORAL RINSE- hydrogen peroxide liquid 
Elba, Inc.

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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MedPak Peroxide Oral Rinse

DRUG FACTS

Active Ingredinet:

Hydrogen Peroxide 1.5%

Purpose

Oral Debriding Agent

Uses

  • Aids in the romoval of phlegm, mucus, or other secretions in the temporary relief of discomfort due to occasional sore throat and sore mouth.

Warning

Stop use and ask doctor if:

  • Swelling, rash, or fever develop.
  • Severe or persistent sure throat or sore throat accompanied by high feverm headache, annsea, and vomiting occurs.

Do not use 

more than 2 days or administer to children under 3 years of age unless directed by a physician.

Keep out of reach of children

under 3 years of age.

Directions

  • Topical dosage for adults and children 3 years of age and older is a rinse used no more than 4 times daily. For children under 3 years of age, there is no recommended dosage except under the advice and supervision of a dentist or doctor.
  • Use only under health care practitioners supervision.

Other Information

  • Store at room temperature.

Avoid excessive heat. Avoid freezing.

Inactive Ingredinets

Purified Water, Glycerin, Flavor, Sodium Saccharin, Sorbitol, Polysorbate 20, Cetylpyridium Chloride, D&C Green #5

Questions or Comments?

1-248-288-6098

Package Labeling:

LabelLid

MEDPAK PEROXIDE ORAL RINSE 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10031-008
Route of AdministrationORAL
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CETYLPYRIDINIUM (UNII: CUB7JI0JV3)  
CHLORIDAZON (UNII: 26X5RK7X7W)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10031-008-0715 mL in 1 CUP; Type 0: Not a Combination Product03/18/201701/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/18/201701/01/2022
Labeler - Elba, Inc. (108428483)

Revised: 5/2021
Document Id: c1fda82a-2cff-2bc8-e053-2a95a90af4bf
Set id: 4b2a349b-93ba-5ef5-e054-00144ff8d46c
Version: 3
Effective Time: 20210510
 
Elba, Inc.