FDA Label for Hydrogen Peroxide

View Indications, Usage & Precautions

ACTIVE INGREDIENT
PURPOSE
USE
WARNINGS
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
STOP USE AND ASK A DOCTOR IF
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENT
DISCLAIMER
ADVERSE REACTIONS
PRINCIPAL DISPLAY PANEL

Hydrogen Peroxide Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

First Aid Antiseptic

Oral debriding agent

Use

first aid to help prevent the risk of infection in minor cuts, scrapes and burns
aids in the removal of phlegm, mucus, or other secretions associated with occassional sore mouth

Warnings

For external use only

Do Not Use

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

Ask A Doctor Before Use If You Have

deep or pucture wounds, animal bites or serious burns

Stop Use And Ask A Doctor If

the condition persists or gets worse
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 swallowed, get medical help or contact a Poison Control Center right away

Directions

First Aid Antiseptic:

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

Oral Debriding Agent:

adults, children over 2 years of age
mix with equal amount of water
swish around in the mouth over 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 dentist or doctor

Other Information

Keep tightly closed and at controlled room temperature. Do not shake bottle. Hold away from face when opening

Inactive Ingredient

water

Disclaimer

CARDINAL HEALTH and the Cardinal Health

LOGO are trademarks or registered trademarks of Cardinal Health.

Adverse Reactions

Distributed by: Cardinal Health

Waukegan, L 60085 USA

cardinalhealth.com 05/15

Principal Display Panel

NDC 63517-450-43

Hydrogen

Peroxide 3%

first aid antiseptic

oral debriding agent

DO NOT USE IF PACKAGE OPENED OR DAMAGED

TEMPERATURE LIMITATION 68°F - 77°F 20°C - 25°C

Not Made with Natural Rubber Latex

For Individual, Professional, and Hospital Use

Cat. AS-HPL16