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Product NDC Code | 82870-006 | ||||
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Drug Name | Acne spot treatment |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 317152 | ||||
Application Number | M006 | ||||
Labeler Name | Dime Beauty Co, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: Salicylic Acid 2% Purpose: Acne medication
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: Clean the skin thoroughly before applying this product 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 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, Propanediol, Lactobacillus Ferment, Pentylene Glycol, Polyacrylate Crosspolymer-6, Octyldodecanol, Glycerin, 1,2-Hexanediol, Glycine Soja (Soybean) Oil, Laminaria Digitata Extract, Sodium Hydroxide, Artemisia Vulgaris Extract, Hydroxyacetophenone, Sea Water, Tetrasodium Glutamate Diacetate, Leptospermum Scoparium Branch/Leaf Oil, Magnolia Officinalis Bark Extract, Piper Nigrum (Pepper) Seed Extract, Chlorella Vulgaris Extract, Dicaprylyl Ether, Phragmites Kharka Extract, Poria Cocos Extract, Lauryl Alcohol, Magnolia Grandiflora Bark Extract, Saccharide Isomerate, Aloe Barbadensis Leaf Juice, Helichrysum Italicum Extract, Avena Sativa (Oat) Kernel Extract
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.Skin irritation and 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.
Purpose
Information about the drug product’s indications for use.Uses: For the treatment of acne
Spl product data elements
Usually a list of ingredients in a drug product.Acne Spot Treatment Salicylic Acid ARTEMISIA VULGARIS ROOT MANUKA OIL MAGNOLIA OFFICINALIS BARK MAGNOLIA GRANDIFLORA BARK HYDROXYACETOPHENONE SODIUM HYDROXIDE FU LING PROPANEDIOL CHLORELLA VULGARIS HELICHRYSUM ITALICUM FLOWER WHITE PEPPER LIMOSILACTOBACILLUS FERMENTUM PROPYLENE GLYCOL AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) SODIUM CHLORIDE SALICYLIC ACID SALICYLIC ACID DICAPRYLYL ETHER WATER OAT ALOE VERA LEAF SACCHARIDE ISOMERATE 1,2-HEXANEDIOL SOYBEAN OIL LAMINARIA DIGITATA LAURYL ALCOHOL OCTYLDODECANOL GLYCERIN TETRASODIUM GLUTAMATE DIACETATE
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.DIME ACNE SPOT TREATMENT SALICYLIC ACID + PROBIOTICS 0.5 FL OZ | 15 ML Acne Spot Bottle Acne Spot 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, get medical help ro contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Questions? (801) 996-8274 [email protected]
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.Warning: For external use only
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