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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. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENT
    12. PRINCIPAL DISPLAY PANEL - 473 ML BOTTLE LABEL

Hydrogen Peroxide Product Label

The following document was submitted to the FDA by the labeler of this product Dyad Medical Sourcing, Llc. 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 the removal of phlegm, mucous, or other secretions associated with occasional sore mouth

Otc - Do Not Use



For external use only

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 or puncture 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

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.


Directions




First aid antiseptic:
  • clean the affected area
  • apply a small amount of product on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first
Oral debriding agent (oral rinse):
adults and children 2 years of age and 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


Principal Display Panel - 473 Ml Bottle Label



HCS

NDC 53175-001-16

Solution of

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - PeroxideFront

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - PeroxideFront


Hydrogen Peroxide
3% USP 10 Volume


FIRST AID ANTISEPTIC
ORAL DEBRIDING AGENT

For treatment of minor cuts, scrapes and burns

For use as a gargle or rinse

For external use only

SEALED FOR YOUR PROTECTION

IF SEAL IS BROKEN OR MISSING DO NOT USE

Manufactured for:Dyad Medical Sourcing, LLC

2101 Waukegan Road, Suite 208 Bannockburn, IL 60015

1-855-241-1773 • [email protected]

Made in USA #902-HCS0202 Rev. 02

©2020 Dyad Medical Sourcing, LLC www.hcsmed.com

Reorder No. HCS0202

16 FL OZ (1 PT) 473 mL

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - PeroxideFront

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - PeroxideFront


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