Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8faf0d37-86e8-4829-a778-f934e4927b5e
Route
TOPICAL
Published
Effective Date 2021-03-08
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 NOT FINAL Active Since 2021-02-25

Description

Hydrogen peroxide 3%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Hydrogen peroxide 3%

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.

Warnings

For external use only. Do not use: In the eyes over large areas of the body, or for longer than 1 week. Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.

Stop use immediately and consult your physician if: The condition persists or worsens after use. If sore mouth symptoms do not improve in 7 days, If irritation, pain or redness persist or worsen. If swelling, rash or fever develop.

Directions

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

bandaged, let dry first • 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 before use.

Product Label

Active Ingredient

Hydrogen peroxide 3%

Other Information

Keep tightly closed in a cool dark place • Do not shake bottle • Hold away from face when opening.

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.

Inactive Ingredient

Water

Keep Out of Reach of Children

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


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, mucous or other secretions associated with occasional sore mouth.

Purpose

Antiseptic

Warnings

For external use only. Do not use: In the eyes over large areas of the body, or for longer than 1 week. Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.

Stop use immediately and consult your physician if: The condition persists or worsens after use. If sore mouth symptoms do not improve in 7 days, If irritation, pain or redness persist or worsen. If swelling, rash or fever develop.

Directions

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

bandaged, let dry first • 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 before use.

Product Label (Product label)

Active Ingredient (Active ingredient)

Hydrogen peroxide 3%

Other Information (Other information)

Keep tightly closed in a cool dark place • Do not shake bottle • Hold away from face when opening.

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.

Inactive Ingredient (Inactive ingredient)

Water

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 at 1-800-222-1222.


Advanced Ingredient Data


Raw Label Data

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