Active Ingredients
BENZOYL PEROXIDE 10%
SULFUR 3%
Smart Release Bpo
FDA Label NDC 73110-105
10 label sections · Submitted to the FDA by Skinclinical Ai, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skinclinical Ai, Llc for the product Smart Release Bpo (NDC 73110-105). 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, use, warnings, other information, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
TREATMENT OF ACNE
Use
For the treatment of acne.
Warnings
For External Use Only.
When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.
- If irritation occurs, only use 1 topical acne medication at a time.
- Avoid unnecessary sun exposure and use a sunscreen.
- Avoid contact with the eyes, lips and mouth.
- Avoid contact with hair or dyed fabrics, which may be bleached by this product. Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.
- Irritation may be reduced by usi ng the product less frequently or in a lower concentration.
Do not use if you have very sensitive skin or sensitive to benzoyl peroxide.
Other Information
Keep tightly closed.
Protect from excessive heat (40° / 140° F) and protect from freezing
Otc - Stop Use
Stop use and ask a doctor if irritation or sensitivity develops.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Important to use on a clean face. Cover the affected area with a thin layer 1 to 3 times per day. Because of excessive drying of the skin may occur, start with 1 application per day then gradually increase to 2 applications per day 1 morning and one evening if needed, or as directed by a doctor. If dryness or peeling occurs, reduce use to once a day or once every other day. If going outside, use a sunscreen. If irritation or sensitivity develops stop using both products and ask a doctor.
Inactive Ingredients
Water (Aqua), Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-8 SMDI Copolymer, Lactobacillus Ferment, Glycolic Acid, Lactic Acid, Magnesium Aluminum SIlicate, Citric Acid, Xanthan Gum, Potassium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Hydrolyzed Algin, Zinc Sulfate, Disodium EDTA, Citrus Aurantium Bergamia (Bergamo!} Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Tangerina (Tangerine) Peel Oil
Questions?
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