drug facts

drug facts
SPL v5
SPL
SPL Set ID 9417b340-942b-48bf-bbfd-4cd5154082b9
Route
topical
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrogen peroxide (2.65 mL)
Inactive Ingredients
water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-01-07

Purpose

first aid antiseptic/oral debriding agent

Description

Hydrogen peroxide 3%


Medication Information

Warnings

For external use only.

Uses
  • 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 occasional sore mouth
Purpose

first aid antiseptic/oral debriding agent

Directions

For use as a first aid antiseptic:

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

For use as an 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 affected area for at least 1 minute and then spit out. Do not swallow.
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
  • children under 12 years 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 and in a dark place at room temperature.
  • Do not shake bottle. Hold away from face when opening.
Description

Hydrogen peroxide 3%

Do Not Use
  • in the eyes or apply over large areas of the body
  • longer than one week
Package Label

WINCO FOODS Hydrogen Peroxide 3% USP
 

Active Ingredient

Hydrogen peroxide 3%

Inactive Ingredient

purified water

Questions Or Comments?

Or to report an adverse event call 800-824-1706 Monday-Friday 9am - 4pm MST

Princiapl Display Panel

Hydrogen Peroxide 3% USP

FIRST AID ANTISEPTIC /

ORAL DEBRIDING AGENT

For Treatment of Minor Cuts & Abrasions

For Use as a Gargle or Rinse

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

Stop Use and Ask A Doctor If
  • swelling, rash, or fever develops
  • the condition persists or gets worse
  • sore mouth symptoms do not improve in 7 days 
  • irritation, pain or redness persists or worsens
Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Have
  • deep or puncture wounds, animal bites or serious burns

Structured Label Content

Warnings

For external use only.

Uses
  • 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 occasional sore mouth
Purpose

first aid antiseptic/oral debriding agent

Directions

For use as a first aid antiseptic:

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

For use as an 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 affected area for at least 1 minute and then spit out. Do not swallow.
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
  • children under 12 years should be supervised in the use of this product
  • children under 2 years of age: consult a dentist or doctor
Other Information (Other information)
  • Keep tightly closed and in a dark place at room temperature.
  • Do not shake bottle. Hold away from face when opening.
Do Not Use (Do not use)
  • in the eyes or apply over large areas of the body
  • longer than one week
Package Label

WINCO FOODS Hydrogen Peroxide 3% USP
 

Active Ingredient (Active ingredient)

Hydrogen peroxide 3%

Inactive Ingredient (Inactive ingredient)

purified water

Questions Or Comments? (Questions or comments?)

Or to report an adverse event call 800-824-1706 Monday-Friday 9am - 4pm MST

Princiapl Display Panel

Hydrogen Peroxide 3% USP

FIRST AID ANTISEPTIC /

ORAL DEBRIDING AGENT

For Treatment of Minor Cuts & Abrasions

For Use as a Gargle or Rinse

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • swelling, rash, or fever develops
  • the condition persists or gets worse
  • sore mouth symptoms do not improve in 7 days 
  • irritation, pain or redness persists or worsens
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds, animal bites or serious burns

Advanced Ingredient Data


Raw Label Data

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