Active Ingredients
Benzoyl Peroxide 5%
Bubble Fade Away Acne Spot Treatment Emulsion
FDA Label NDC 83509-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bubble Beauty for the product Bubble Fade Away Acne Spot Treatment (NDC 83509-003). 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 ingredients, purpose, uses, warnings, do not use if you, when using this product, stop use and ask a 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
Acne Medication
Uses
- For the treatment of acne
- Helps clear acne blemishes, acne pimples, blackheads, and whiteheads and allows skin to heal.
Warnings
For external use only.
Do Not Use If You
- have very sensitive skin
- are sensitive to benzoyl peroxide
When Using This Product
- skin irritation or dryness may occur if you use another topical acne medication at the same time. If irritation occurs, use one medication at a time
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the eyes, lips, and mouth
- avoid contact with hair and dyed fabrics, which may be bleached
- redness, burning, itching, peeling, or possibly swelling may occur. Irritation may be reduced by using the product less or in a lower concentration.
Stop Use And Ask A Doctor If
- irritation becomes severe.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Clean the skin thoroughly before applying this product.
- Cover the entire affected area with a thin layer one to three times daily.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Other Information
- Avoid storing at extreme temperatures (Below 40F and above 100F).
Inactive Ingredients
Water (Aqua), Glycerin, Propanediol, Carbomer, Glycyrrhiza Glabra (Licorice) Root Extract, Niacinamide, Allantoin, Zinc Pca, Laureth-4, Xanthan Gum, Aloe Barbadensis Leaf Juice, Diethylhexyl Sodium Sulfosuccinate, Sambucus Nigra Fruit Juice, Spiraea Ulmaria Flower Extract, Sodium Hydroxide, Sodium Citrate, Sodium Phytate, Potassium Sorbate, Citric Acid, Sodium Benzoate, Sodium Sulfite
Questions Or Comments?
Call +1 (651) 504-2243
Product Packaging
1 (Fadeaway)
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