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

Description

Hydrogen peroxide (stabilized) 3%

Purpose

First aid antiseptic Oral debriding agent


Medication Information

Purpose

First aid antiseptic

Oral debriding agent

Description

Hydrogen peroxide (stabilized) 3%

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
Warnings

For external use only

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

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%

Other Information

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

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

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

Warnings

For external use only

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

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%

Other Information (Other information)

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

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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