Booboo Bubbles

Booboo Bubbles
SPL v1
SPL
SPL Set ID 3e8b538c-d4d6-7d76-e063-6394a90a96d1
Routes
BUCCAL TOPICAL
Published
Effective Date 2025-09-15
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 DRUG Active Since 2025-09-15

Description

Hydrogen Peroxide 3%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Hydrogen Peroxide 3%

Warnings

For external use except when used as an oral rinse

Directions

For antiseptic use Clean the affected area. Apply a small amount on the area 1 to 3 times daily.

For oral rinse use Adults and children 2 years and older: Mix with an equal amount of water and swish around and over the affected area, then spit out. Use up to 4 times daily or as directed by a dentist or doctor. Children under 2 years of age: Consult a doctor.

Do Not Use

Do not use in the eyes

Do not apply over large areas of the body

Do not use longer than 1 weeks unless directed by a dentist or doctor

Indications

As an antiseptic to help prevent infection in minor cuts, scrapes, burns.

As an oral rinse for temporary use in cleaning minor wounds or irritation/inflammation to the mouth and gums resulting from minor dental procedures, orthodontic appliances or accidental injury.

Active Ingredient

Hydrogen Peroxide 3%

Front Panel Label

Other Information

Keep tightly closed and at controlled room temperature 15 o-30 oC (59 o-86 oF). Do not shake.

Inactive Ingredient

Purified water

Keep Out of Reach of Children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Cernter immediately.

Ask A Doctor Before Use If You Have

Deep or puncture wounds

Animal bites

Serious burns

Sop Use and Consult A Dentist Or Doctor If

condition persists or gets worse

sore mouth symptoms do not improve in 7 days

irritation, pain, redness or fever develop


Structured Label Content

Purpose

Antiseptic

Warnings

For external use except when used as an oral rinse

Directions

For antiseptic use Clean the affected area. Apply a small amount on the area 1 to 3 times daily.

For oral rinse use Adults and children 2 years and older: Mix with an equal amount of water and swish around and over the affected area, then spit out. Use up to 4 times daily or as directed by a dentist or doctor. Children under 2 years of age: Consult a doctor.

Do Not Use (Do not use)

Do not use in the eyes

Do not apply over large areas of the body

Do not use longer than 1 weeks unless directed by a dentist or doctor

Indications

As an antiseptic to help prevent infection in minor cuts, scrapes, burns.

As an oral rinse for temporary use in cleaning minor wounds or irritation/inflammation to the mouth and gums resulting from minor dental procedures, orthodontic appliances or accidental injury.

Active Ingredient

Hydrogen Peroxide 3%

Front Panel Label

Other Information

Keep tightly closed and at controlled room temperature 15 o-30 oC (59 o-86 oF). Do not shake.

Inactive Ingredient

Purified water

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion, seek professional assistance or contact a Poison Control Cernter immediately.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

Deep or puncture wounds

Animal bites

Serious burns

Sop Use and Consult A Dentist Or Doctor If (Sop use and consult a dentist or doctor if)

condition persists or gets worse

sore mouth symptoms do not improve in 7 days

irritation, pain, redness or fever develop


Advanced Ingredient Data


Raw Label Data

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