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| Product NDC Code | 14222-1600 | ||||
|---|---|---|---|---|---|
| Drug Name | Spotless regimen for acne, blemishes and breakouts |
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| Type | Brand | ||||
| Route | TOPICAL | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 200009, 308696 |
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| 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 Ingredient Benzoyl Peroxide 5%
Active Ingredient 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 Wet skin with lukewarm water. Using fingertips, apply a thin, even layer and massage over entire face for 90 seconds, avoiding all contact with eyes. Rinse thoroughly and pat dry. Use once daily and increase to twice daily as tolerated. Wash hands after application to help avoid staining fabrics. 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.
Directions Clean the skin thoroughly before applying this product. Dispense 1-2 pumps and 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, Polyacrylamide, C13-14 Isoalkane, Jojoba Esters, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Cocamidopropyl Betaine, Laureth-7, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Propanediol, Ethylhexylglycerin, Phenoxyethanol, Sodium Benzoate.
Inactive Ingredients Water, Glycereth-18 Ethylhexanoate, Glycereth-18, Disiloxane, Glycerin, Butylene Glycol, Propanediol, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Allantoin, Ascorbyl Palmitate, Bisabolol, Myristyl Alcohol, PCA, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Polygonum Cuspidatum Root Extract, Sodium Hyaluronate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Fragrance/Parfum, Carbomer, Methyl Methacrylate Crosspolymer, Cetyl Hydroxyethylcellulose, Hydroxyphenyl Propamidobenzoic Acid, Polyglyceryl-2 Isostearate, Polysorbate 80, Sorbitan Oleate, Xanthan Gum, Diethylhexyl Sodium Sulfosuccinate, Isohexadecane, Dimethyl Isosorbide, Tocopherol, Citric Acid, Sodium Citrate, Sodium Hydroxide, Caprylyl Glycol, Decylene Glycol, Hexylene Glycol, Pentylene Glycol, 1,2-Hexanediol, Ethylhexylglycerin, Hydroxyacetophenone, Phenoxyethanol, Citral, Citronellol, Limonene, Linalool, Mica, Tin Oxide, Titanium Dioxide, Blue 1 (Cl 42090), Ext. Violet 2 (Cl 60730), Red 33 (Cl 17200).
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.
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
Purpose Acne Treatment
Spl product data elements
Usually a list of ingredients in a drug product.SPOTLESS Regimen for Acne, Blemishes and Breakouts Benzoyl Peroxide SPOTLESS Daily Acne Wash Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE WATER POLYACRYLAMIDE (10000 MW) C13-14 ISOPARAFFIN CARBOXYPOLYMETHYLENE COCAMIDOPROPYL BETAINE DOCUSATE SODIUM ETHYLHEXYLGLYCERIN HYDROGENATED JOJOBA OIL, RANDOMIZED LAURETH-7 PHENOXYETHANOL PROPANEDIOL SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SODIUM HYDROXIDE SPOTLESS Acne Clearing Treatment Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE WATER GLYCERETH-18 ETHYLHEXANOATE GLYCERETH-18 HEXAMETHYLDISILOXANE GLYCERIN BUTYLENE GLYCOL PROPANEDIOL 1,2-HEXANEDIOL ALLANTOIN ASCORBYL PALMITATE CAPRYLYL GLYCOL CETYL HYDROXYETHYLCELLULOSE (350000 MW) CITRIC ACID MONOHYDRATE D&C RED NO. 33 Ext. D&C VIOLET NO. 2 DECYLENE GLYCOL DIMETHYL ISOSORBIDE DOCUSATE SODIUM ETHYLHEXYLGLYCERIN FD&C BLUE NO. 1 GINGER HEXYLENE GLYCOL HYALURONATE SODIUM HYDROXYACETOPHENONE HYDROXYPHENYL PROPAMIDOBENZOIC ACID ISOHEXADECANE LEVOMENOL LOWBUSH BLUEBERRY METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER MICA MYRISTYL ALCOHOL PENTYLENE GLYCOL PHENOXYETHANOL PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE PIDOLIC ACID POLYGLYCERYL-2 ISOSTEARATE POLYSORBATE 80 REYNOUTRIA JAPONICA ROOT SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) SODIUM CITRATE, UNSPECIFIED FORM SODIUM HYDROXIDE SORBITAN MONOOLEATE STANNIC OXIDE TITANIUM DIOXIDE TOCOPHEROL XANTHAN GUM
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 - Kit Label RODAN+FIELDS SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS DESIGNED FOR TEENS AND YOUNG ADULTS Eliminates acne-causing bacteria Helps clear blackheads, whiteheads and pimples Helps prevent new blemishes from forming Reduces shine DEVELOPED BY STANFORD-TRAINED DERMATOLOGISTS DR.KATIE RODAN AND DR.KATHY FIELDS Daily Acne Wash Benzoyl Peroxide Cream 125 mL/4.2 Fl. Oz. U.S. Acne Clearing Treatment Benzoyl Peroxide Lotion* 50 mL/1.7 Fl. Oz. U.S. Principal Display Panel - Kit Label
Principal Display Panel - Acne Clearing Treatment Tube Label RODAN+FIELDS SPOTLESS ACNE CLEARING TREATMENT 2 Principal Display Panel - Acne Clearing Treatment Tube Label
Principal Display Panel - Daily Acne Wash Tube Label RODAN+FIELDS SPOTLESS DAILY ACNE WASH 1 Principal Display Panel - Daily Acne Wash Tube Label
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.Daily Acne Wash Drug Facts
Acne Clearing Treatment Drug Facts
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.
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.
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). This product may bleach hair or dyed fabrics.
Other Information Store between 15-30°C (59-86°F). This product may bleach hair or dyed fabrics.
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
Questions? 1-888-995-5656 *When both lotion and gel are combined equally, Benzoyl Peroxide is 2.5%
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 and ask a doctor if Skin irritation becomes severe.
Stop and ask a doctor if Skin 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.
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 and ask a doctor if Skin irritation becomes severe. Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
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 and ask a doctor if Skin 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