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  5. Label Information: Hydrogen Peroxide

FDA Label for Hydrogen Peroxide

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENT
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 3.79 L BOTTLE LABEL

Hydrogen Peroxide Product Label

The following document was submitted to the FDA by the labeler of this product Henry Schein Inc.. 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.

Other



Drug Facts


Active Ingredient



Hydrogen Peroxide (stabilized) 3%


Purpose



First Aid Antiseptic/Oral Debriding Agent


Uses



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

Warnings



For external use only


Otc - Do Not Use



Do not use

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

Otc - Ask Doctor



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


Otc - Stop Use



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

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Directions



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

Oral Debriding Agent (oral rinse):

Adults and children 2 years of age & over:

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

Other Information



  • Keep tightly closed in a cool dark place
  • Do not shake bottle
  • Hold away from face when opening

Inactive Ingredient



Purified Water


Questions Or Comments?



1-800-472-4346


Principal Display Panel - 3.79 L Bottle Label



Item # 112-7070
NDC 0404-0001-01

HENRY SCHEIN®

3 % Hydrogen
Peroxide Solution

U.S.P. FIRST AID ANTISEPTIC
Tamper evident cap for your protection. If ring-band
is detached from cap or missing do not use.

Distributed by (in US Only):

HENRY SCHEIN INC.
135 Duryea Road
Melville, NY 11747 USA

Rev. Date 2018/06 Made in the USA

128 FL OZ (1 Gal.) • 3.79 L

Principal Display Panel - 3.79 L Bottle Label - peroxide 01

Principal Display Panel - 3.79 L Bottle Label - peroxide 01


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