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| Product NDC Code | 71819-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Salicylic acid |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOAP | ||||
| RxCUI drug identifier | 562600 | ||||
| Application Number | part333D | ||||
| Labeler Name | D3 Development, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic acid 2%
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 Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne, avoiding contact with eyes. Rinse thoroughly and pat dry with a clean towel Because bothersome dryness of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed 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 Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, titanium dioxide, table salt, olive oil, Avena Sativa (oat) kernel flour, pentasodium pentetate, tocopheryl acetate (vitamin E)
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 Reduces the number of acne pimples and allows skin to heal Penetrates pores to clear most acne blemishes Dries up acne pimples Helps keep skin clear of new acne blemishes, acne pimples, whiteheads, and blackheads
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.Salicylic Acid Salicylic Acid SODIUM CHLORIDE TITANIUM DIOXIDE WATER SODIUM COCOATE GLYCERIN SALICYLIC ACID SALICYLIC ACID OATMEAL SODIUM PALM KERNELATE OLIVE OIL SODIUM PALMATE .ALPHA.-TOCOPHEROL ACETATE, D- PENTASODIUM PENTETATE
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.dermaharmony Salicylic Acid SOAP For Acne, Whiteheads, & Blackheads NET WT 4.0 OZ (113 G) SalicylicAcid-FINAL 05-07-18
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
Distributed by: D3 Development, Inc., Portland, ME 04101 Made in the USA
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-827-3730 www.dermaharmony.com
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 may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a doctor.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature Lot number and expiration date are printed on back panel.
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