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| Product NDC Code | 76162-264 | ||||
|---|---|---|---|---|---|
| Drug Name | Daily acne control cleanser |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M006 | ||||
| Labeler Name | Topco Associates LLC | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reactions DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 TOPCO VIJ0422 QUESTIONS? 1-888-423-0139 [email protected] QUALITY GUARANTEED Scan here for more information or call 1-888-423-0139 *This product is not manufactured or distributed by the Johnson Consumer Products Company, distributor of Clean & Clear Continuous Control Acne Cleanser.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzoyl peroxide 10%
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 wet face. Gently massage all over face for 20-30 seconds avoiding the eyes. Rinse thoroughly and pat dry. 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 daily 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 Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas, during the first 3 days. If no discomfort occurs, follow the directions stated above.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, cetyl alcohol, petrolatum, acrylates/C10-30 alkyl acrylate crosspolymer, zinc lactate, steareth-2, glycerin, potassium cetyl phosphate, xanthan gum, benzyl alcohol, fragrance, disodium EDTA, laureth-4, BHT, sodium hydroxide, lactic acid, menthol
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.Use for the treatment of acne
Purpose
Information about the drug product’s indications for use.Purpose Acne medication
Spl product data elements
Usually a list of ingredients in a drug product.Daily Acne Control Cleanser Benzoyl peroxide WATER CETYL ALCOHOL PETROLATUM CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ZINC LACTATE STEARETH-2 GLYCERIN POTASSIUM CETYL PHOSPHATE XANTHAN GUM BENZYL ALCOHOL EDETATE DISODIUM ANHYDROUS LAURETH-4 MENTHOL 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.principal display panel TopCare beauty DAILY ANCE CONTROL CLEANSER 10% Benzoyl Peroxide Acne Medication Compare to CLEAN & CLEAR* Keeps fighting acne even after you wash PARABEN FREE .NET WT 5 OZ (141 g) image description
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
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. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information keep tightly closed store at room temperature (59⁰-77⁰)
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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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 bleaced 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
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
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