Active Ingredient
Hydrogen Peroxide 3%
Booboo Bubbles Solution
FDA Label NDC 85324-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by 72 Seasons Llc for the product Booboo Bubbles (NDC 85324-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, indications, warnings, do not use, ask a doctor before use if you have, sop use and consult a dentist or doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
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.
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.
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 Information
Keep tightly closed and at controlled room temperature 15 o-30 oC (59 o-86 oF). Do not shake.
Inactive Ingredient
Purified water
* Please review the disclaimer below.
