Hydrgnperxde3%dlta

Hydrgnperxde3%dlta
SPL v2
SPL
SPL Set ID cffcaa32-9793-365d-e053-2a95a90adc63
Route
TOPICAL
Published
Effective Date 2021-11-04
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 2021-11-02

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 (as a first aid antiseptic).

Directions

for use as a first aid antiseptic: Clean the affected area. Apply a small amount of this product on affected area 1to 3 times a daily.

May be covered with a sterile bandage. If bandaged, let dry first

For use as an oral debriding agent:

Adults and children 2 years of age and older: Mix with an equal amount of warm water. Swish around in the mouth over affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

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

Do Not Use

in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor

Package Label

Active Ingredient

Hydrogen peroxide (stabilized) 3%

Other Information

keep tightly closed and at controlled room temperature. Do not shake bottle. Hold away from face when opening

Inactive Ingredients

purified water

Keep Out of Reach of Children.

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

Stop Use and Consult A Doctor If

the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

As oral debriding agent:

Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or swelling, rash, or fever develops, see your dentist or doctor promptly


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 (as a first aid antiseptic).

Directions

for use as a first aid antiseptic: Clean the affected area. Apply a small amount of this product on affected area 1to 3 times a daily.

May be covered with a sterile bandage. If bandaged, let dry first

For use as an oral debriding agent:

Adults and children 2 years of age and older: Mix with an equal amount of warm water. Swish around in the mouth over affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

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

Do Not Use (Do not use)

in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor

Package Label

Active Ingredient (Active ingredient)

Hydrogen peroxide (stabilized) 3%

Other Information (Other information)

keep tightly closed and at controlled room temperature. Do not shake bottle. Hold away from face when opening

Inactive Ingredients (Inactive ingredients)

purified water

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.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)

the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

As oral debriding agent:

Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or swelling, rash, or fever develops, see your dentist or doctor promptly


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