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Product NDC Code | 59427-005 | ||||
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Drug Name | Super spot remover acne treatment |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 416212, 2468334 |
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Application Number | M006 | ||||
Labeler Name | ORIGINS NATURAL RESOURCES INC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic Acid 1.5%
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 Cleanse skin thoroughly before applying 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 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 alcohol denat.,hamamelis virginiana (witch hazel) water,water\aqua\eau,acrylates/c10-30 alkyl acrylate crosspolymer,cucumis sativus (cucumber) fruit extract,pyrus malus (apple) fruit extract,scutellaria baicalensis root extract,algae extract,poria cocos sclerotium extract,laminaria saccharina extract,lactobacillus ferment,glycerin,caffeine,butylene glycol,tocopheryl acetate,magnesium ascorbyl phosphate,sodium hydroxide,eugenia caryophyllus (clove) bud oil1,origanum heracleoticum flower oil1,eugenol,sodium sulfite,sodium metabisulfite,disodium edta,phenoxyethanol
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 management of acne clears acne blemishes helps prevent development 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.SUPER SPOT REMOVER ACNE TREATMENT SALICYLIC ACID SODIUM SULFITE SODIUM METABISULFITE EDETATE DISODIUM ANHYDROUS HAMAMELIS VIRGINIANA TOP WATER ORIGANUM VULGARE SUBSP. HIRTUM FLOWER WATER CLOVE OIL EUGENOL CUCUMBER APPLE SCUTELLARIA BAICALENSIS ROOT SACCHARINA LATISSIMA GLYCERIN CAFFEINE BUTYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE MAGNESIUM ASCORBYL PHOSPHATE SODIUM HYDROXIDE PHENOXYETHANOL SALICYLIC ACID SALICYLIC ACID FU LING LIMOSILACTOBACILLUS FERMENTUM PORPHYRIDIUM PURPUREUM ALCOHOL ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)
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.ORIGINS Super Spot Remover ™ Acne treatment gel salicylic acid 1.5% .3 fl. oz./oz. liq./10 ml e CARTON
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, call a doctor 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 medication at the same time. If this occurs, only use one toptical acne medication at the same time. If this 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. Keep out of reach of children. If swallowed, call a doctor or contact a Poison Control Center right away. When using this product skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If this occurs, only use one toptical acne medication at the same time. If this 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