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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 1.50%
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. Apply a thin layer 1 to 3 times daily or as needed. If dryness or peeling occurs, reduce application to every other day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water\aqua\eau • alcohol denat. • acrylates/c10-30 alkyl acrylate crosspolymer • hamamelis virginiana (witch hazel) • eugenia caryophyllus (clove) bud oil essential oil , origanum heracleoticum flower oil , eugenol, limonene • 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 • phenoxyethanol <iln37864>
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
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 ORIGANUM VULGARE SUBSP. HIRTUM FLOWER WATER WITCH HAZEL CLOVE OIL EUGENOL CUCUMBER APPLE SCUTELLARIA BAICALENSIS ROOT SACCHARINA LATISSIMA GLYCERIN CAFFEINE BUTYLENE GLYCOL PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE MAGNESIUM ASCORBYL PHOSPHATE SODIUM HYDROXIDE SALICYLIC ACID SALICYLIC ACID ALCOHOL CARBOMER 1342 FU LING LIMOSILACTOBACILLUS FERMENTUM PORPHYRIDIUM PURPUREUM
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.PRINCIPAL DISPLAY PANEL - 10 ml Carton ORIGINS Super Spot Remover ™ Acne treatment gel salicylic acid .3 fl. oz./oz. liq./ 10 ml e Principal Display Panel - 10 ml Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
© Origins Nat. Res., Dist. New York, NY 10022
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.
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. Avoid eye area. Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Keep out of reach of children. If swallowed, call a doctor or contact a Poison Control Center right away.
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