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Breakout control bioelements - Medication Information

Product NDC Code 49825-129
Drug Name

Breakout control bioelements

Type Brand
Active Ingredients
Benzoyl peroxide 5 g/100ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 308693
Application Number M006
Labeler Name Bioelements, Inc.
Packages
Package NDC Code Description
49825-129-02 1 bottle in 1 carton (49825-129-02) / 29 ml in 1 bottle (49825-129-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Purpose Benzoyl Peroxide 5% Acne treatment Uses For the treatment of acne Helps prevent new acne blemishes Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away Stop use and ask a doctor if: irritation becomes severe Warnings For external use only When using this product - Skin irritation and dryness is more likely to occur if you use antoher topical acne medication at the same time. If irritation occurs only use only one topical acne medication at a time. - Avoid unnecessary sun exposure and use a sunscreen - Avoid contact with with the eyes lips and mouth - Avoid contact with hair and 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 using the product less frequently or in a lower concentration. - Do not use if you: Have very sensitive skin Are sensitive to benzoyl peroxide Directions Cleanse the skin thoroughly before applying this product cover the entire 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 If going outside apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a doctor. Inactive ingredients Water (Aqua,Eau), Pentylene Glycol, Hydroxyethyl Acrylates/Sodium Acryloyldimethyl Taurate Copolymer, Squalene, Polysorbate 60, Aloe Bardadensis (Aloe) Leaf Juice powder, Phytic Acid, Phyenoxyethanol, Potassium Sorbate, Disodium EDTA.

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Cleanse the skin thoroughly before applying this product cover the entire 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 If going outside apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a doctor. Inactive ingredients Water (Aqua,Eau), Pentylene Glycol, Hydroxyethyl Acrylates/Sodium Acryloyldimethyl Taurate Copolymer, Squalene, Polysorbate 60, Aloe Bardadensis (Aloe) Leaf Juice powder, Phytic Acid, Phyenoxyethanol, Potassium Sorbate, Disodium EDTA.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water (Aqua,Eau), Pentylene Glycol, Hydroxyethyl Acrylates/Sodium Acryloyldimethyl Taurate Copolymer, Squalene, Polysorbate 60, Aloe Bardadensis (Aloe) Leaf Juice powder, Phytic Acid, Phyenoxyethanol, Potassium Sorbate, Disodium EDTA.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Stop use and ask a doctor if: irritation becomes severe Warnings For external use only When using this product - Skin irritation and dryness is more likely to occur if you use antoher topical acne medication at the same time. If irritation occurs only use only one topical acne medication at a time. - Avoid unnecessary sun exposure and use a sunscreen - Avoid contact with with the eyes lips and mouth - Avoid contact with hair and 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 using the product less frequently or in a lower concentration. - Do not use if you: Have very sensitive skin Are sensitive to benzoyl peroxide Directions Cleanse the skin thoroughly before applying this product cover the entire 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 If going outside apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a doctor. Inactive ingredients Water (Aqua,Eau), Pentylene Glycol, Hydroxyethyl Acrylates/Sodium Acryloyldimethyl Taurate Copolymer, Squalene, Polysorbate 60, Aloe Bardadensis (Aloe) Leaf Juice powder, Phytic Acid, Phyenoxyethanol, Potassium Sorbate, Disodium EDTA.

Purpose

Information about the drug product’s indications for use.
Uses For the treatment of acne Helps prevent new acne blemishes Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away Stop use and ask a doctor if: irritation becomes severe Warnings For external use only When using this product - Skin irritation and dryness is more likely to occur if you use antoher topical acne medication at the same time. If irritation occurs only use only one topical acne medication at a time. - Avoid unnecessary sun exposure and use a sunscreen - Avoid contact with with the eyes lips and mouth - Avoid contact with hair and 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 using the product less frequently or in a lower concentration. - Do not use if you: Have very sensitive skin Are sensitive to benzoyl peroxide Directions Cleanse the skin thoroughly before applying this product cover the entire 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 If going outside apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a doctor. Inactive ingredients Water (Aqua,Eau), Pentylene Glycol, Hydroxyethyl Acrylates/Sodium Acryloyldimethyl Taurate Copolymer, Squalene, Polysorbate 60, Aloe Bardadensis (Aloe) Leaf Juice powder, Phytic Acid, Phyenoxyethanol, Potassium Sorbate, Disodium EDTA.

Spl product data elements

Usually a list of ingredients in a drug product.
Breakout Control Bioelements Benzoyl Peroxide WATER PENTYLENE GLYCOL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) SQUALANE POLYSORBATE 60 FYTIC ACID PHENOXYETHANOL POTASSIUM SORBATE EDETATE DISODIUM BENZOYL PEROXIDE BENZOYL PEROXIDE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Bioelements Breakout control 5% benzoyl peroxide acne treatment invisibly spot treats to clear acne breakouts 29 mL/ 1 Fl. Oz. Bottle Box

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away Stop use and ask a doctor if: irritation becomes severe Warnings For external use only When using this product - Skin irritation and dryness is more likely to occur if you use antoher topical acne medication at the same time. If irritation occurs only use only one topical acne medication at a time. - Avoid unnecessary sun exposure and use a sunscreen - Avoid contact with with the eyes lips and mouth - Avoid contact with hair and 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 using the product less frequently or in a lower concentration. - Do not use if you: Have very sensitive skin Are sensitive to benzoyl peroxide Directions Cleanse the skin thoroughly before applying this product cover the entire 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 If going outside apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a doctor. Inactive ingredients Water (Aqua,Eau), Pentylene Glycol, Hydroxyethyl Acrylates/Sodium Acryloyldimethyl Taurate Copolymer, Squalene, Polysorbate 60, Aloe Bardadensis (Aloe) Leaf Juice powder, Phytic Acid, Phyenoxyethanol, Potassium Sorbate, Disodium EDTA.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only When using this product - Skin irritation and dryness is more likely to occur if you use antoher topical acne medication at the same time. If irritation occurs only use only one topical acne medication at a time. - Avoid unnecessary sun exposure and use a sunscreen - Avoid contact with with the eyes lips and mouth - Avoid contact with hair and 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 using the product less frequently or in a lower concentration. - Do not use if you: Have very sensitive skin Are sensitive to benzoyl peroxide Directions Cleanse the skin thoroughly before applying this product cover the entire 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 If going outside apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a doctor. Inactive ingredients Water (Aqua,Eau), Pentylene Glycol, Hydroxyethyl Acrylates/Sodium Acryloyldimethyl Taurate Copolymer, Squalene, Polysorbate 60, Aloe Bardadensis (Aloe) Leaf Juice powder, Phytic Acid, Phyenoxyethanol, Potassium Sorbate, Disodium EDTA.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API