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Product NDC Code | 43479-114 | ||||
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Drug Name | Eradikate clarifying acne cleanser |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 1038982 | ||||
Application Number | M006 | ||||
Labeler Name | KATE SOMERVILLE SKINCARE, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS SALICYLIC ACID 1%
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 AM & PM. DISPENSE A QUARTER SIZED AMOUNT AND MASSAGE GENTLY ONTO WET FACE, AVOIDING EYE AREA. RINSE THOROUGHLY AND PAT DRY. 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 AQUA/WATER/EAU, COCAMIDOPROPYL HYDROXYSULTAINE, DISODIUM COCOYL GLUTAMATE, MALTOOLIGOSYL GLUCOSIDE, HYDROGENATED STARCH HYDROSYLATE, PROPANEDIOL, SODIUM COCOYL GLUTAMATE, NIACINAMIDE, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, GLYCERIN, LACTOBACILLUS FERMENT, CITRULLUS VULGARIS (WATERMELON) FRUIT EXTRACT, LENS ESCULENTA (LENTIL) FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, PEG-9 COCOATE, POLYGLYCERYL-6 RICINOLEATE, POLYGLYCERYL-6 CAPRYLATE, POLYGLYCERYL-4 COCOATE, POLYGLYCERYL-4 CAPRATE, PROPYLENE GLYCOL, POLYSORBATE 20, PEG-32 DISTEARATE, PEG-175 DISTEARATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, 1,2-HEXANEDIOL, SACCHARIDE ISOMERATE, SODIUM LACTATE, SODIUM PCA, POLYDEXTROSE, DEXTRIN, AMYLOPECTIN, MALTODEXTRIN, THYMOL, TERPINEOL, SORBETH-450 TRISTEARATE, CAPRYLHYDROXAMIC ACID, SODIUM CITRATE, SODIUM BENZOATE, POTASSIUM SORBATE, CITRIC ACID, SODIUM CHLORIDE, DISODIUM EDTA, SODIUM HYDROXIDE
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 HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES
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.ERADIKATE CLARIFYING ACNE CLEANSER SALICYLIC ACID WATER COCAMIDOPROPYL HYDROXYSULTAINE DISODIUM COCOYL GLUTAMATE MALTOOLIGOSYL GLUCOSIDE HYDROGENATED STARCH HYDROLYSATE PROPANEDIOL SODIUM COCOYL GLUTAMATE NIACINAMIDE ROSEMARY OIL GLYCERIN LACTOBACILLUS FERMENTUM WATERMELON LENTIL APPLE PEG-9 OLEATE POLYGLYCERYL-6 RICINOLEATE POLYGLYCERYL-6 CAPRYLATE POLYGLYCERYL-4 OLEATE POLYGLYCERYL-4 CAPRATE PROPYLENE GLYCOL POLYSORBATE 20 PEG-32 DISTEARATE PEG-175 DISTEARATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 1,2-HEXANEDIOL SACCHARIDE ISOMERATE SODIUM LACTATE SODIUM PYRROLIDONE CARBOXYLATE POLYDEXTROSE ICODEXTRIN AMYLOPECTIN, UNSPECIFIED SOURCE MALTODEXTRIN THYMOL TERPINEOL SORBETH-12 CAPRYLHYDROXAMIC ACID SODIUM CITRATE SODIUM BENZOATE POTASSIUM SORBATE ANHYDROUS CITRIC ACID SODIUM CHLORIDE EDETATE DISODIUM SODIUM HYDROXIDE 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.01b UC__EradiKate Clarifying Acne Gel Cleanser_4oz
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 PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A 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 EXTERNAL USE ONLY WHEN USING THIS PRODUCT SKIN IRRITATION OR 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 RASH OCCURS.
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