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Acne spot treatment - Medication Information

Product NDC Code 76354-413
Drug Name

Acne spot treatment

Type Brand
Active Ingredients
Salicylic acid 18 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 2568117
Application Number M006
Labeler Name e.l.f. Cosmetics, Inc
Packages
Package NDC Code Description
76354-413-15 1 bottle in 1 box (76354-413-15) / 15 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Salicylic Acid 1.8% Purpose Acne Treatment

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 the skin thoroughly before applying medication. 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 neede or a 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), Alcohol Denat., PPg-26-Buteth-26, Aloe Barbadensis Leaf Juice, Niacinamide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polyacrylate Crosspolymer-6, PEG-40 Hydrogenated Castor Oil, Acacia Seneggl Gum, Salix Alba (Willow) Bark Extract, Zinc PCA, Dipotassium Glycyrrhizate, Portulaca Oleracea Extract, Propanediol, Caprylyl glycol, Ethylhexylglycerin, Phenoxyethanol, Citric acid, Limonene

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 prevent 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.
Acne Spot Treatment SALICYLIC ACID WATER ALCOHOL PPG-26-BUTETH-26 ALOE VERA LEAF NIACINAMIDE TEA TREE OIL AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) POLYOXYL 40 HYDROGENATED CASTOR OIL ACACIA SALIX ALBA BARK ZINC PIDOLATE GLYCYRRHIZINATE DIPOTASSIUM PURSLANE PROPANEDIOL CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN PHENOXYETHANOL CITRIC ACID MONOHYDRATE LIMONENE, (+)- 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.
Package Labeling: Label11

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.

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? 1-888-315-9814

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if rash occurs.

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 eyes. Rinse with water to remove. 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. Stop use and ask a doctor if rash occurs. 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