MedPath

Booboo Bubbles

Booboo Bubbles

Approved
Approval ID

3e8b538c-d4d6-7d76-e063-6394a90a96d1

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

72 Seasons LLC

DUNS: 113832998

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydrogen Peroxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85324-001
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Hydrogen Peroxide
Product Specifications
Route of AdministrationBUCCAL, TOPICAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (2)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROGEN PEROXIDEActive
Quantity: 30 mg in 1 mL
Code: BBX060AN9V
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/15/2025

Front Panel Label

Front Panel Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/15/2025

Indications

As an antisepticto 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.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/15/2025

Active Ingredient

Hydrogen Peroxide 3%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/15/2025

Purpose

Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 9/15/2025

Warnings

For external use except when used as an oral rinse

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

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

Keep out of reach of children

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/15/2025

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.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/15/2025

Other Information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/15/2025

Inactive Ingredient

Purified water

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Booboo Bubbles - FDA Drug Approval Details