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Product NDC Code | 83509-002 | ||||
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Drug Name | Bubble knock out acne spot treatment |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | EMULSION | ||||
RxCUI drug identifier | 416909 | ||||
Application Number | M006 | ||||
Labeler Name | BUBBLE BEAUTY | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Salicylic Acid 1.8%
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 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), PENTYLENE GLYCOL, SODIUM POLYACRYLATE, POLYACRYLATE CROSSPOLYMER-6, GAULTHERIA PROCUMBENS (WINTERGREEN) LEAF EXTRACT, GLYCERIN, AZELAIC ACID, SALIX NIGRA (WILLOW) BARK EXTRACT, ALOE BARBADENSIS LEAF JUICE, ZINC PCA, DIPOTASSIUM GLYCYRRHIZATE, SAMBUCUS NIGRA FRUIT JUICE, SPIRAEA ULMARIA FLOWER EXTRACT, CITRIC ACID, SODIUM HYDROXIDE, 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 treatment of acne Helps clear acne blemishes, acne pimples, blackheads, and whiteheads and allows skin to heal.
Purpose
Information about the drug product’s indications for use.Purpose Acne Medication
Spl product data elements
Usually a list of ingredients in a drug product.Bubble Knock Out Acne Spot Treatment Salicylic Acid PENTYLENE GLYCOL SODIUM POLYACRYLATE (2500000 MW) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) SALIX NIGRA BARK GAULTHERIA PROCUMBENS LEAF AZELAIC ACID SALICYLIC ACID SALICYLIC ACID FILIPENDULA ULMARIA FLOWER ALOE VERA LEAF ZINC PIDOLATE EUROPEAN ELDERBERRY JUICE CITRIC ACID MONOHYDRATE SODIUM HYDROXIDE WATER PHENOXYETHANOL GLYCERIN GLYCYRRHIZINATE DIPOTASSIUM
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.Product Packaging 1
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
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Avoid storing at extreme temperatures (Below 40F and above 100F).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call +1 (651) 504-2243
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 or dryness may occur, especiallly if used with other topical acne medication. If it occurs, use only one acne treatment at a time, and reduce usage to every other day.
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 may occur, especiallly if used with other topical acne medication. If it occurs, use only one acne treatment at a time, and reduce usage to every other day. Keep out of reach of children. If swallowed, get medical help 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