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| Product NDC Code | 14222-2120 | ||||
|---|---|---|---|---|---|
| Drug Name | Unblemish dual intensive acne treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 200009 | ||||
| Application Number | part333D | ||||
| Labeler Name | Rodan & Fields | ||||
| 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 Ingredients Benzoyl Peroxide 2.5%
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 thoroughly before applying this product. Dispense 1-2 pumps from each side. Blend product evenly. Cover the entire affected area with a thin even layer one to three times daily. Do not rinse product off face. 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. Wash hands after application to help avoid staining fabrics.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Ethoxydiglycol, Glycerin, Polyacrylamide, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Allantoin, Niacinamide, Panthenol, Punica Granatum Fruit Extract, Yucca Glauca Root Extract, Ceramide AP, Ceramide EOP, Ceramide NP, Fragrance (Parfum), Biosaccharide Gum-1, Disodium Cocamido MIPA-Sulfosuccinate, Carbomer, Cholesterol, Leuconostoc/Radish Root Ferment Filtrate, Corn Starch Modified, Phytosphingosine, Sodium Lauroyl Lactylate, Xanthan Gum, Laureth-7, Aminomethyl Propanol, Disodium Oleamido MEA-Sulfosuccinate, Cl3-14 lsoparaffin, PEG-7 Glyceryl Cocoate, BHT, Disodium EDTA, Ethylhexylglycerin, Benzyl Alcohol, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool
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.Uses For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads, and whiteheads.
Purpose
Information about the drug product’s indications for use.Purpose Acne treatment
Spl product data elements
Usually a list of ingredients in a drug product.UNBLEMISH Dual Intensive Acne Treatment BENZOYL PEROXIDE BENZOYL PEROXIDE BENZOYL PEROXIDE WATER DIETHYLENE GLYCOL MONOETHYL ETHER GLYCERIN POLYACRYLAMIDE (10000 MW) .BETA.-CITRONELLOL, (R)- ALLANTOIN ALOE VERA LEAF AMINOMETHYLPROPANOL BENZYL ALCOHOL BIOSACCHARIDE GUM-1 BUTYLATED HYDROXYTOLUENE C13-14 ISOPARAFFIN CARBOXYPOLYMETHYLENE CERAMIDE 1 CERAMIDE AP CERAMIDE NP CHOLESTEROL DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE EDETATE DISODIUM ANHYDROUS ETHYLHEXYLGLYCERIN GERANIOL LAURETH-7 LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE LIMONENE, (+)- LINALOOL, (+/-)- MATRICARIA CHAMOMILLA FLOWERING TOP NIACINAMIDE PANTHENOL PEG-7 GLYCERYL COCOATE PHENOXYETHANOL PHYTOSPHINGOSINE POMEGRANATE SODIUM LAUROYL LACTYLATE STARCH, CORN XANTHAN GUM YUCCA GLAUCA ROOT
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 - 45mL / 1.5 Fl. Oz. Carton Label RODAN+FIELDS UMBLEMISH 3 Dual Intensive Acne Treatment RODAN+FIELDS 2 x 22.5 mL/0.76 Fl. Oz. U.S. Principal Display Panel - 45mL / 1.5 Fl. Oz. Carton Label
Principal Display Panel - 45mL / 1.5 Fl. Oz. Tube Label RODAN+FIELDS UMBLEMISH 3 Dual Intensive Acne Treatment Principal Display Panel - 45mL / 1.5 Fl. Oz. Tube Label
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store between 15-30°C (59-86°F).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions 1-888-995-5656
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.
When using this product 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.
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 another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Do not use if you Have very sensitive skin. Are sensitive to benzoyl peroxide. When using this product 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