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| Product NDC Code | 52261-7300 | ||||
|---|---|---|---|---|---|
| Drug Name | Sofie pavitt face reset benzoyl peroxide acne treatment mask |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 308696 | ||||
| Application Number | M006 | ||||
| Labeler Name | Cosco International, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient/Purpose Benzoyl Peroxide............Acne Treatment
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 Clean the skin throughly before applying this product Apply to hands, add and massage gently onto the face. Allow to dry. Rinse thoroughly. Use 1 to 2 times daily or as directed by a doctor. If dryness of 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 consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Kaolin, Bentonite, Propanediol, Sodium Hyaluronate, Methyl Gluceth-20, Phenoxyethanol, Ethylhexylglycerin, Glycolic Acid, Niacinamide, Panthenol, Hydroxyethylcellulose, Xanthan Gum, Retinyl Palmitate, Tocopheryl Acetate
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.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 one 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 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. 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.
Purpose
Information about the drug product’s indications for use.Use For the treatment of acne
Spl product data elements
Usually a list of ingredients in a drug product.Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask Benzoyl Peroxide Benzoyl Peroxide BENZOYL PEROXIDE WATER KAOLIN BENTONITE PROPANEDIOL HYALURONATE SODIUM METHYL GLUCETH-20 PHENOXYETHANOL ETHYLHEXYLGLYCERIN GLYCOLIC ACID NIACINAMIDE PANTHENOL HYDROXYETHYL CELLULOSE, UNSPECIFIED XANTHAN GUM VITAMIN A PALMITATE .ALPHA.-TOCOPHEROL ACETATE
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.60ml tube
60ml carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other Information Store at room temperature 20°-25°C (68°-77°F)
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask doctor before use if you have redness over the affected area 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 one 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 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. 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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have very sensitive skin are sensitive to benzoyl peroxide Ask doctor before use if you have redness over the affected area 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 one 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 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. 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.
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 a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
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 Do not use if you have very sensitive skin are sensitive to benzoyl peroxide Ask doctor before use if you have redness over the affected area 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 one 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 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. 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.
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