Hydrogen Peroxide Topical Solution U.s.p.

Hydrogen Peroxide Topical Solution U.s.p.
SPL v1
SPL
SPL Set ID 25d77750-8904-4f5f-85ba-8efe9ba9d3e3
Route
TOPICAL
Published
Effective Date 2021-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (30 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-01-01

Description

Hydrogen Peroxide 3%

Purpose

First Aid Antiseptic


Medication Information

Purpose

First Aid Antiseptic

Description

Hydrogen Peroxide 3%

Uses

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

Warnings

For External Uses only, avoid swallowing

Do Not Use

in the eyes or apply over large areas of the body longer than one week.

Active Ingredient

Hydrogen Peroxide 3%

Other Information

Keep tightly closed and in dark place at room temperature. Do not shake bottle. Hold away from face when opening

Package Labeling:

Inactive Ingredient

USP Water

Stop Use and Ask Doctor If:

condition persist or worsens, sore mouth symptoms do not improve in 7 days irritation pain or redenss persists or worsens swelling, rash of fever develops. Deep puncture wounds animal bites or serious burns.

Keep Out of Reach of Children.

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

Direcction for Use A First Aid Antiseptic

Clean affected area. Apply small amount of product on affected area 1-3 times day. May be covered with a sterile bandage. If bandaged let dry first.

FOR USE AS AN ORAL RINSE AGENT

Adults and children 2 years of age and over: mix with an equal amount of water. Swish around mouth over the affected area for at least 1 minute and then spilt out. Do Not Swallow. Use up to 4 times daily or as directed by your dentist or doctor.


Structured Label Content

Uses (USES)

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

Purpose

First Aid Antiseptic

Warnings

For External Uses only, avoid swallowing

Do Not Use (DO NOT USE)

in the eyes or apply over large areas of the body longer than one week.

Active Ingredient

Hydrogen Peroxide 3%

Other Information

Keep tightly closed and in dark place at room temperature. Do not shake bottle. Hold away from face when opening

Package Labeling:

Inactive Ingredient

USP Water

Stop Use and Ask Doctor If: (Stop use and ask doctor if:)

condition persist or worsens, sore mouth symptoms do not improve in 7 days irritation pain or redenss persists or worsens swelling, rash of fever develops. Deep puncture wounds animal bites or serious burns.

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.

Direcction for Use A First Aid Antiseptic (DIRECCTION FOR USE A FIRST AID ANTISEPTIC)

Clean affected area. Apply small amount of product on affected area 1-3 times day. May be covered with a sterile bandage. If bandaged let dry first.

FOR USE AS AN ORAL RINSE AGENT

Adults and children 2 years of age and over: mix with an equal amount of water. Swish around mouth over the affected area for at least 1 minute and then spilt out. Do Not Swallow. Use up to 4 times daily or as directed by your dentist or doctor.


Advanced Ingredient Data


Raw Label Data

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