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Product NDC Code | 43479-113 | ||||||
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Drug Name | Eradikate mattifying acne |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
RxCUI drug identifier | 417424 | ||||||
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 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.AM AND/OR PM. APPLY A THIN, EVEN LAYER TO CLEAN, DRY SKIN. AVOID EYE AREA. SHOULD BE APPLIED AFTER TREATMENT STEP AND BEFORE MAKEUP + SPF. BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO OR THREE TIMES DAILY, THEN GRADUALLY INCREASE TO TWO OT THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. 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, KAOLIN, ISODODECANE, MAGNESIUM ALUMINUM SILICATE, NIACINAMIDE, DIMETHICONE, PROPANEDIOL, BUTYLENE GLYCOL, HYDROLYZED YEAST PROTEIN, POLYSILICONE-11, POLYACRYLATE CROSSPOLYMER-6, PPG-26-BUTETH-26, CURCUMA WENYUJIN/CURCUMA KWANGSIENSIS RHIZOME EXTRACT, ORYZA SATIVA (RICE) BRAN EXTRACT, MEL/HONEY EXTRACT/EXTRAIT DE MIEL, BOSWELLIA SERRATA EXTRACT, SODIUM HYALURONATE, PROLINE, HYDROXYPROLINE, ETHYLHEXYLGLYCERIN, HYDROLYZED VEGETABLE PROTEIN, NORDIHYDROGUAIARETIC ACID, OLEANOLIC ACID, BIOTIN, SODIUM PCA, 1,2-HEXANEDIOL, GLYCERYL STEARATE, PEG-40 HYDROGENATED CASTOR OIL, CETEARYL ALCOHOL, CETEARETH-20, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCO-CAPRYLATE/CAPRATE, PEG-100 STEARATE, HYDROXYETHYLCELLULOSE, SACCHARIDE ISOMERATE, ETHYL LINOLEATE, PEG-60 ALMOND GLYCERIDES, CAPRYLYL GLYCOL, GLYCERIN, PHOSPHOLIPIDS, HYDROGENATED VEGETABLE OIL, PENTYLENE GLYCOL, TOCOPHERYL ACETATE, PANTHENOL, T-BUTYL ALCOHOL, DECYL GLUCOSIDE, SODIUM CITRATE, HEXYLENE GLYCOL, CARBOMER, HEXYLRESORCINOL, CAPRYLHYDROXAMIC ACID, XANTHAN GUM, THYMOL, TERPINEOL, SODIUM HYDROXIDE, DISODIUM EDTA, PHENOXYETHANOL, SODIUM METABISULFITE, SODIUM BENZOATE, CITRIC ACID
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 Mattifying Acne SALICYLIC ACID NIACINAMIDE DIMETHICONE PROPANEDIOL BUTYLENE GLYCOL YEAST, UNSPECIFIED DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) PPG-26-BUTETH-26 CURCUMA AROMATICA ROOT CURCUMA KWANGSIENSIS ROOT RICE BRAN HONEY BOSWELLIA SERRATA WHOLE HYALURONATE SODIUM PROLINE HYDROXYPROLINE ETHYLHEXYLGLYCERIN LUTEIN NORDIHYDROGUAIARETIC ACID, (+/-)- OLEANOLIC ACID BIOTIN SODIUM PYRROLIDONE CARBOXYLATE 1,2-HEXANEDIOL GLYCERYL MONOSTEARATE POLYOXYL 40 HYDROGENATED CASTOR OIL CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER MEDIUM-CHAIN TRIGLYCERIDES COCO-CAPRYLATE/CAPRATE PEG-100 STEARATE HYDROXYETHYL CELLULOSE, UNSPECIFIED SACCHARIDE ISOMERATE ETHYL LINOLEATE PEG-60 ALMOND GLYCERIDES CAPRYLYL GLYCOL GLYCERIN OMEGA-3 FATTY ACIDS HYDROGENATED COTTONSEED OIL PENTYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE PANTHENOL TERT-BUTYL ALCOHOL DECYL GLUCOSIDE SODIUM CITRATE, UNSPECIFIED FORM HEXYLENE GLYCOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE HEXYLRESORCINOL CAPRYLHYDROXAMIC ACID XANTHAN GUM THYMOL TERPINEOL SODIUM HYDROXIDE EDETATE SODIUM PHENOXYETHANOL SODIUM METABISULFITE SODIUM BENZOATE ANHYDROUS CITRIC ACID SALICYLIC ACID SALICYLIC ACID WATER KAOLIN ISODODECANE MAGNESIUM ALUMINUM SILICATE
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 Mattifying Gel_1.7oz
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? VISIT WWW.KATESOMERVILLE.COM OR CALL 1-800-984-5283.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION STORE IN A COOL, DRY PLACE.
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.
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