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| Product NDC Code | 67226-1021 | ||||
|---|---|---|---|---|---|
| Drug Name | Medicated wash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 562600 | ||||
| Application Number | M006 | ||||
| Labeler Name | Vivier Pharma, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Salicylic Acid USP 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 Wet face using lukewarm water. Gently massage over the face using fingertips. Rinse completely. Use both morning and night or as directed by a physician. If dryness or peeling occurs, reduce application to once a day or every other day. Other Information Store at room temperature (15-30°C / 59-86°F).
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Acrylates Copolymer, Alcohol, Citric Acid, Disodium Cocoamphodiacetate, Disodium Cocoyl Glutamate, DMDM Hydantoin, Ethoxydiglycol, Fragrance, Hexamidine Diisethionate, PEG-7 Glyceryl Cocoate, PEG-120 Methyl Glucose Dioleate, Sodium Hydroxide, Sodium Lauroyl Sarcosinate, Water / Eau.
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. Dries, clears and helps keep skin clear of new acne pimples, blackheads and white heads.
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.Medicated Wash SALICYLIC ACID ALCOHOL CITRIC ACID MONOHYDRATE DISODIUM COCOAMPHODIACETATE DISODIUM COCOYL GLUTAMATE DMDM HYDANTOIN DIETHYLENE GLYCOL MONOETHYL ETHER HEXAMIDINE DIISETHIONATE PEG-7 GLYCERYL COCOATE PEG-120 METHYL GLUCOSE DIOLEATE SODIUM HYDROXIDE SODIUM LAUROYL SARCOSINATE WATER SALICYLIC ACID SALICYLIC ACID
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.Package Label Label 1 Label 2 Label 3
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 Poison Control Center right away.
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 exrernal use only Ask a doctor before use if you are Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor When using this product Do not get into eyes. Stop use and ask a doctor if Excessive skin irritation develops or increases.
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