MEDPAK PEROXIDE ORAL RINSE- hydrogen peroxide liquid

MedPak Peroxide Oral Rinse by

Drug Labeling and Warnings

MedPak Peroxide Oral Rinse by is a Otc medication manufactured, distributed, or labeled by Elba, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

MEDPAK PEROXIDE ORAL RINSE 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10031-008
Route of Administration	ORAL

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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10031-008-07	15 mL in 1 CUP; Type 0: Not a Combination Product	03/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/18/2017

Labeler - Elba, Inc. (108428483)