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Blemish control basics kit - Medication Information

Product NDC Code 76354-417
Drug Name

Blemish control basics kit

Type Brand
Dosage Form KIT
RxCUI drug identifier 417424,
1038982,
2593955
Application Number M006
Labeler Name e.l.f. Cosmetics, Inc
Packages
Package NDC Code Description
76354-417-01 1 kit in 1 kit (76354-417-01) * 1 bottle in 1 carton (76354-415-02) / 30 ml in 1 bottle * 1 bottle in 1 carton (76354-416-02) / 30 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% Purpose Acne Treatment Active ingredients Salicylic Acid 1% 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 needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated eleswhere on this label. 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 needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated eleswhere on this label.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Glycerin, Zinc PCA, Sodium Benzoate, Hydroxypropyl Methylcellulose, Sodium Hydroxide, Sodium Chloride, Citric Acid, Disodium EDTA, Niacinamide, Tranexamic Acid May Contain: Blue 1 (CI 42090), Yellow 5 (CI 19140) Inactive ingredients Water (Aqua), Niacinamide, Glycerin, Silica, Propanediol, Isododecane, Tranexamic Acid, Glyceryl Stearate Citrate, C12-15 Alkyl Benzoate, Acetyl Glucosamine, Tromethamine, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Cetearyl Alcohol, Capryloyl Glycine, Potassium Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Tocopherol, Helianthus Annuus (Sunflowe) Seed Oil, Disodium EDTA, Caprylic Acid, Sodium Citrate May Contain: Chromium Oxide Greens (CI 77288), Iron Oxides (CI 77492)

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 Uses For the treatment of acne Helps prevent new acne blemishes

Purpose

Information about the drug product’s indications for use.
Purpose Acne Treatment Purpose Acne Treatment

Spl product data elements

Usually a list of ingredients in a drug product.
Blemish Control Basics Kit SALICYLIC ACID Acne Clarifying Cleanser SALICYLIC ACID WATER SODIUM C14-16 OLEFIN SULFONATE COCAMIDOPROPYL BETAINE GLYCERIN ZINC PIDOLATE SODIUM BENZOATE HYPROMELLOSE, UNSPECIFIED SODIUM HYDROXIDE SODIUM CHLORIDE CITRIC ACID MONOHYDRATE EDETATE DISODIUM ANHYDROUS NIACINAMIDE TRANEXAMIC ACID SALICYLIC ACID SALICYLIC ACID Acne Calming Water Cream SALICYLIC ACID WATER NIACINAMIDE GLYCERIN SILICON DIOXIDE PROPANEDIOL ISODODECANE TRANEXAMIC ACID GLYCERYL STEARATE CITRATE ALKYL (C12-15) BENZOATE N-ACETYLGLUCOSAMINE TROMETHAMINE ALUMINUM STARCH OCTENYLSUCCINATE PHENOXYETHANOL CETOSTEARYL ALCOHOL CAPRYLOYL GLYCINE POTASSIUM CETYL PHOSPHATE ALLANTOIN XANTHAN GUM CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN TOCOPHEROL SUNFLOWER OIL EDETATE DISODIUM ANHYDROUS CAPRYLIC ACID SODIUM CITRATE 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: Kit kit Package Labeling: 30ml label30 Package Labeling: 30ml cream

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 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. 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 Questions or comments 1-888-315-9814

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 acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. When using this product 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.

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 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Warnings For external use only. When using this product 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. 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