DYNAREX HP 3- hydrogen peroxide liquid

Dynarex HP 3 by

Drug Labeling and Warnings

Dynarex HP 3 by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation, Blossom Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                       Purpose

Hydrogen peroxide 3% v/v                         Antiseptic

                                                                   Oral debriding agent

PURPOSE

First aid to help prevent the risk of infection in:

• minor cuts
• scrapes
• burns
• aids in the removal of phlegm, mucus, or other secretions associated with occassional sore mouth.

WARNINGS

• For external use only
• Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.

• Stop use and ask a doctor if condition persist or gets worse.
• Sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens
• swelling rash or fever develops

INDICATIONS & USAGE

Do not use:

• in the eyes or over large areas of the body
• longer than 1 week

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

IIf swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

DIRECTIONS as a  First Aid Antiseptic:

• clean the affected area
• apply a small amount of this product on the affected area 1 to 3 times a day
• may be covered with a sterile bandage
• if bandaged let dry first

DIRECTIONS as a Oral Debriding Agent:

Adults, children over 2 years of age:

• mix with an equal amount of water
• swish around the mouth in the affected area for at least 1 minute, then spit out
• use up to 4 times daily after meals and at bedtime
• children under 12 years of age should be supervised in the use
• children under 2 years of age consult a dentis or doctor

OTHER INFORMATION

• keep tightly closed and at controlled room temperature.
• do not shake bottle
• Hold away from face when opening

INACTIVE INGREDIENT

Inactive Ingredient

• Water
  

PRINCIPAL DISPLAY PANEL

DYNAREX 3% Hydrogen Peroxide

Hydrogen Peroxide.jpg

INGREDIENTS AND APPEARANCE

DYNAREX HP 3 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	2.65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-306-01	118 mL in 1 BOTTLE
2	NDC: 67777-306-02	454 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/29/2014

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Blossom Pharmaceuticals		677381470	manufacture(67777-306)