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| Product NDC Code | 43479-112 | ||||
|---|---|---|---|---|---|
| Drug Name | Eradikate acne mark fading |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 346298 | ||||
| Application Number | M006 | ||||
| Labeler Name | KATE SOMERVILLE SKINCARE, LLC | ||||
| 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 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.DIRECTIONS AM AND PM. APPLY TO TARGETED AREAS OR ALL OVER A CLEANSED AND DRIED FACE, AVOIDING EYE AREA. ALLOW TO FULLY ABSORB INTO THE SKIN. BECAUSE EXCESSIVE DRYING OF THE SKIN MAKE OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO OR 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 WATER/AQUA/EAU, COCONUT ALKANES, PENTYLENE GLYCOL, NIACINAMIDE, CAPRYLYL METHICONE, GLYCERIN, CETEARYL OLIVATE, POLYSILICONE-11, POTASSIUM CETYL PHOSPHATE, SORBITAN OLIVATE, CARBOMER, MICROCITRUS AUSTRALIS FRUIT EXTRACT, LENS ESCULENTA (LENTIL) FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CITRULLUS lANATUS (wATERMELON) FRUIT EXTRACT, CITRUS GLAUCA FRUIT EXTRACT, SODIUM LACTATE, PHYTOSPHINGOSINE, ADENOSINE, DECYL GLUCOSIDE, 1,2-HEXANEDIOL, SODIUM PCA, ALPHA-GLUCAN OLIGOSACCHARIDE, MALTODEXTRIN, POLYGLYCERYL-3 CAPRATE, BUTYLENE GLYCOL, AMINOMETHYL PROPANOL, POLYSORBATE 20, CAPRYLHYDROXAMIC ACID, ZINC PCA, THYMOL, TERPINEOL, HEXYLENE GLYCOL, CAPRYLYL GLYCOL, POLYDEXTROSE, DEXTRIN, AMYLOPECTIN, LACTOBACILLUS FERMENT, PHENOXYETHANOL, DISODIUM EDTA, SODIUM BENZOATE, POTASSIUM SORBATE
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 ACNE MARK FADING SALICYLIC ACID WATER COCONUT ALKANES PENTYLENE GLYCOL NIACINAMIDE CAPRYLYL TRISILOXANE GLYCERIN CETEARYL OLIVATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) POTASSIUM CETYL PHOSPHATE SORBITAN OLIVATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE MICROCITRUS AUSTRALIS FRUIT LENTIL APPLE WATERMELON EREMOCITRUS GLAUCA FRUIT SODIUM LACTATE PHYTOSPHINGOSINE ADENOSINE DECYL GLUCOSIDE 1,2-HEXANEDIOL SODIUM PYRROLIDONE CARBOXYLATE .ALPHA.-GLUCAN OLIGOSACCHARIDE MALTODEXTRIN POLYGLYCERYL-3 CAPRATE BUTYLENE GLYCOL AMINOMETHYLPROPANOL POLYSORBATE 20 CAPRYLHYDROXAMIC ACID ZINC PIDOLATE THYMOL TERPINEOL HEXYLENE GLYCOL CAPRYLYL GLYCOL POLYDEXTROSE ICODEXTRIN AMYLOPECTIN, UNSPECIFIED SOURCE LACTOBACILLUS REUTERI PHENOXYETHANOL EDETATE DISODIUM SODIUM BENZOATE POTASSIUM SORBATE 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 Acne Fading Gel
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 MEDICATIONAT 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