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| Product NDC Code | 11086-038 | ||||
|---|---|---|---|---|---|
| Drug Name | Keralyt 3 percent |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 283602, 688067 |
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| Application Number | M032 | ||||
| Labeler Name | Summers Laboratories 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 3%
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 TO AFFECTED AREA ONE TO FOUR TIMES DAILY OR AS DIRECTED BY A DOCTOR.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS PROPYLENE GLYCOL, SD-40 ALCOHOL (21%), WATER, HYDROXYPROPYLCELLULOSE
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 HELPS STOP THESE SYMPTOMS OF PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF FLAKING SCALING REDNESS IRRITATION ITCHING
Purpose
Information about the drug product’s indications for use.PURPOSE PSORIASIS, SEBORRHEIC DERMATITIS
Spl product data elements
Usually a list of ingredients in a drug product.Keralyt 3 PERCENT salicylic acid PROPYLENE GLYCOL ALCOHOL HYDROXYPROPYL CELLULOSE 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.Keralyt 3-SA_Unit Carton
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.ASK A DOCTOR BEFORE USE IF CONDITION COVERS A LARGE AREA OF THE BODY WHEN USING THIS PRODUCT DO NOT GET INTO EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. IF IRRITATION PERSISTS, CONSULT A DOCTOR. STOP USE AND CONSULT A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE. KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. FLAMMABLE
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. IN CASE OF ACCIDENTAL INGESTION, 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.FLAMMABLE
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 CONSULT A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE.
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 DO NOT GET INTO EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. IF IRRITATION PERSISTS, CONSULT A DOCTOR.
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