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| Product NDC Code | 42851-085 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Zo skin health oil control pads acne treatment |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PATCH | ||||||
| RxCUI drug identifier | 797892 | ||||||
| Application Number | M006 | ||||||
| Labeler Name | ZO Skin Health, 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 Salicylic Acid 2.0%
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. 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 Alcohol, Artemisia Vulgaris Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Crithmum Maritimum Extract, Fragrance, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Extract, Hordeum Vulgare Seed Extract, Mandelic Acid, Menthyl Lactate, Phenoxyethanol, Phellodendron Amureuse Extract, Plantago Lanceolata Leaf Extract, Pterocarpus Soyauxii Wood Extract, Rosa Canina Fruit Extract, Sodium Hydroxide, Spiraea Ulmaria Extract, Urea, Water.
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 management of acne. Penetrates pores to control acne blemishes.
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.ZO Skin Health Oil Control Pads Acne Treatment Salicylic Acid UREA WATER SALICYLIC ACID SALICYLIC ACID MANDELIC ACID PHELLODENDRON AMURENSE BARK GLYCOLIC ACID TERT-BUTYL ALCOHOL DENATONIUM BENZOATE EDETATE DISODIUM ANHYDROUS GREEN TEA LEAF BUTYLENE GLYCOL CRITHMUM MARITIMUM SODIUM CHLORIDE SODIUM CARBONATE HAMAMELIS VIRGINIANA TOP MENTHYL LACTATE, (-)- PLANTAGO LANCEOLATA LEAF PTEROCARPUS SOYAUXII WOOD ROSA CANINA FRUIT ALCOHOL PHENOXYETHANOL SODIUM HYDROXIDE
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 - 60 Pad Jar Carton ZO ® SKIN HEALTH BY ZEIN OBAGI MD NDC 42851-085-60 OIL CONTROL PADS ACNE TREATMENT 2% Salicylic Acid 60 Pads US Oil Control Pads Full UC 228300
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Recent Changes Summary Contents of Labelling Updates Capitalized the beginning of all sentences in Directions section. Deleted from Other Information section: “Read the directions and warnings before use.” Capitalized sub-heading Active Ingredient Capitalized active ingredient Salicylic Acid 2.0% Revised Active Ingredient’s Purpose from “Acne treatment” to “Acne Medication” Capitalized the beginning of all sentences under Uses section. Bolded “For external use only.” Corrected “Stop use and ask a doctor if” to “Stop use and ask a doctor” Artwork Uploaded unit carton (SKU no. 928300) to replace previous mark-up’s secondary label (SKU no. 925000).
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.Drug Facts
Dist. by ZO Skin Health, Inc. Irvine, CA 92618 Made in USA with US & imported materials zoskinhealth.com | 928300
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 skin 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 medication 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 Flammable. Keep away from heat and open flame. 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. Stop use and ask a doctor if skin 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