980 hydrogen peroxide solution

980 hydrogen peroxide solution
SPL v6
SPL
SPL Set ID 26a67a91-ee2d-6a6c-e054-00144ff88e88
Routes
topical oral
Published
Effective Date 2022-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrogen peroxide (3 mL)
Inactive Ingredients
water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-08-11

Purpose

First aid antiseptic Oral debriding agent

Description

Hydrogen peroxide (stabilized) 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

First aid antiseptic:

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

Oral debriding agent: adults, children over 2 years of age:

  • mix with an 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, doctor

Other Information

Keep tightly closed. Protect from freezing, avoid excessive heat. Do not shake bottle. Hold away from face when opening.

Description

Hydrogen peroxide (stabilized) 3%

Do Not Use
  • in the eyes or apply over large areas of the body
  • longer than 1 week
Package Label

Active Ingredient

Hydrogen peroxide (stabilized) 3%

Inactive Ingredient

purified water

Manufacturing Information

Made in US with US and foreign components for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA



www.medline.com

1-800-MEDLINE (633-5463)

REF: MDS098014

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.

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

First aid antiseptic:

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

Oral debriding agent: adults, children over 2 years of age:

  • mix with an 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, doctor

Other Information (Other information)

Keep tightly closed. Protect from freezing, avoid excessive heat. 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 1 week
Package Label

Active Ingredient (Active ingredient)

Hydrogen peroxide (stabilized) 3%

Inactive Ingredient (Inactive ingredient)

purified water

Manufacturing Information

Made in US with US and foreign components for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA



www.medline.com

1-800-MEDLINE (633-5463)

REF: MDS098014

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center 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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