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Product NDC Code | 44038-2119 | ||||
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Drug Name | Stridex essential |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
Application Number | M004 | ||||
Labeler Name | Accupac LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic Acid 1.0%(w/w)
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 -use the pad to 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 of as directed by a doctor -if bothersome dryness or peeling occurs, reduce application to once a day or every other day -do not use if seal is broken -do not leave pad on skin for an extended period of tme -keep away from eyes, lips and other mucous membranes
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water Ammonium Xylenesulfonate Ammonium Lauryl Sulfate Sodium Citrate Phenoxyethanol Ethylhexyglycerin Sodium Hydroxide Menthol Silicon dioxide Sodium Ascorbyl Phosphate Edetate Sodium Alpha-Tocopherol acetate
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 blackheads and allows skin to heal helps prevent new acne pimples from forming
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.Stridex Essential Salicylic Acid ETHYLHEXYLGLYCERIN EDETATE SODIUM SALICYLIC ACID SALICYLIC ACID SODIUM CITRATE WATER AMMONIUM XYLENESULFONATE AMMONIUM LAURYL SULFATE PHENOXYETHANOL SODIUM HYDROXIDE MENTHOL SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE .ALPHA.-TOCOPHEROL ACETATE
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.label label
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.Allergy alert: do not use this product if you have a known allergy to salicylic acid
Stridex Essential: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Other information DO NOT FLUSH-discard pad in trash and wash hands after use
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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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.
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 Allergy alert: do not use this product if you have a known allergy to salicylic acid 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. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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