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Product NDC Code | 42851-093 | ||||
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Drug Name | Zo skin health retinol plus acne complex |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | M006 | ||||
Labeler Name | ZO Skin Health, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Active Ingredients Purpose Salicylic Acid 2.0% Acne Medication
Salicylic Acid 2.0% | Acne Medication |
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 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 below. Clean the skin thoroughly before applying this product. Cover the entire affected area 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Cocamidopropyl Dimethylamine, Glycerin, Sclerotium Gum, Dimethicone, Silica, Cetyl Glyceryl Ether, Retinol, Cetyl Alcohol, Cetyl Tranexamate Mesylate, Carthamus Tinctorius (Safflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Rosa Canina Fruit Extract, Leontopodium Alpinum Meristem Cell Culture, Marrubium Vulgare Meristem Cell Culture, Lecithin, Propanediol, Potassium Azeloyl Diglycinate, BHT, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Sodium Bisulfite, Sodium Metabisulfite, Sodium Sulfite, Sodium Sulfate, Polysorbate 20, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Butylene Glycol, Isohexadecane, Bakuchiol, Aminomethyl Propanol, Caprylhydroxamic Acid, Disodium EDTA, Polysorbate 80, Phenoxyethanol, Ethylhexylglycerin.
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.Drug Facts Active Ingredients Active Ingredients Purpose Salicylic Acid 2.0% Acne Medication Uses For the management of acne. Penetrates pores to control acne blemishes. Helps prevent new acne blemishes from forming. Warnings For external use only. When using this product skin irritation and dryness is more likely to occur if you use another topical acne mediation at the same time. If irritation occurs, only use one topical acne medication at a time. Stop use and ask a doctor if irritation occurs or gets worse. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions 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 below. Clean the skin thoroughly before applying this product. Cover the entire affected area 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. Other Information Protect this product from excessive heat and direct sun. Inactive Ingredients Water, Cocamidopropyl Dimethylamine, Glycerin, Sclerotium Gum, Dimethicone, Silica, Cetyl Glyceryl Ether, Retinol, Cetyl Alcohol, Cetyl Tranexamate Mesylate, Carthamus Tinctorius (Safflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Rosa Canina Fruit Extract, Leontopodium Alpinum Meristem Cell Culture, Marrubium Vulgare Meristem Cell Culture, Lecithin, Propanediol, Potassium Azeloyl Diglycinate, BHT, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Sodium Bisulfite, Sodium Metabisulfite, Sodium Sulfite, Sodium Sulfate, Polysorbate 20, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Butylene Glycol, Isohexadecane, Bakuchiol, Aminomethyl Propanol, Caprylhydroxamic Acid, Disodium EDTA, Polysorbate 80, Phenoxyethanol, Ethylhexylglycerin.
Salicylic Acid 2.0% | Acne Medication |
Purpose
Information about the drug product’s indications for use.Uses For the management of acne. Penetrates pores to control acne blemishes. Helps prevent new acne blemishes from forming.
Spl product data elements
Usually a list of ingredients in a drug product.ZO Skin Health Retinol Plus Acne Complex Salicylic Acid AMINOMETHYLPROPANOL SALICYLIC ACID SALICYLIC ACID BAKUCHIOL COCAMIDOPROPYL DIMETHYLAMINE RETINOL OLIVE OIL POTASSIUM AZELOYL DIGLYCINATE SODIUM BISULFITE ISOHEXADECANE BUTYLATED HYDROXYTOLUENE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) ETHYLHEXYLGLYCERIN DIMETHICONE, UNSPECIFIED LECITHIN, SUNFLOWER CAPRYLHYDROXAMIC ACID SODIUM SULFATE CETYL GLYCERYL ETHER PROPANEDIOL ROSA CANINA FRUIT WATER SILICON DIOXIDE BETASIZOFIRAN SODIUM METABISULFITE POLYSORBATE 20 BUTYLENE GLYCOL EDETATE DISODIUM PHENOXYETHANOL GLYCERIN POLYSORBATE 80 SODIUM SULFITE SAFFLOWER SEED CETYL ALCOHOL
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 ZO® SKIN HEALTH BY ZEIN OBAGI, MD NDC 42851-093-50 RETINOL + ACNE COMPLEX 50 mL / 1.7 Fl. Oz. Dist. by ZO Skin Health, Inc. Irvine, CA 92618 Made in USA with US & imported materials zoskinhealth.com | 917200 Outer Label
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.For external use only.
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 occurs or gets worse.
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 mediation at the same time. If irritation occurs, only use one topical acne medication at a time.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect this product from excessive heat and direct sun.
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 mediation at the same time. If irritation occurs, only use one topical acne medication at a time. Stop use and ask a doctor if irritation occurs or gets worse. 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