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| Product NDC Code | 76354-121 | ||||
|---|---|---|---|---|---|
| Drug Name | Naturium encapsulated salicylic acid moisturizer 0.75% |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 2391153 | ||||
| Application Number | M006 | ||||
| Labeler Name | e.l.f. Cosmetics, Inc | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Salicylic Acid 0.75%
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. if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use and ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aqua (Water), Propanediol, Butylene Glycol, Octyldodecanol, Dimethicone, Glyceryl Stearate, Coco-Caprylate/Caprate, Glycerin, Cetearyl Alcohol, Triheptanoin, Octadecenedioic Acid, Silybum Marianum Extract, Magnesium PCA, Amylopectin, Niacinamide, Succinoglycan, Bisabolol, Nelumbo Nucifera Flower Water, Nymphaea Caerulea Flower Water, Palmitic Acid, Lecithin, Physalis Angulata Extract, Acetyl Glucosamine, Castor Oil/IPDI Copolymer, Caprylic/Capric Triglyceride, Dilinoleic Acid/Butanediol Copolymer, Carbomer, C9-12 Alkane, Behenyl Alcohol, Stearic Acid, Dipropylene Glycol, Polysorbate 20, Dextrin, Polydextrose, Caprylyl Glycol, 1,2-Hexanediol, Cetyl Alcohol, Lauryl Alcohol, Myristyl Alcohol, Sodium Hydroxide, Phenoxyethanol, Tocopherol.
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 Helps fight existing acne breakouts and prevents future acne breakouts.
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.Naturium Encapsulated Salicylic Acid Moisturizer 0.75% Salicylic Acid NIACINAMIDE C9-12 ALKANE 1,2-HEXANEDIOL BUTYLENE GLYCOL CETOSTEARYL ALCOHOL TRIHEPTANOIN OCTADECENEDIOIC ACID MILK THISTLE MAGNESIUM PIDOLATE WATER AMYLOPECTIN, UNSPECIFIED SOURCE PROPANEDIOL GLYCERIN COCO-CAPRYLATE/CAPRATE GLYCERYL MONOSTEARATE SALICYLIC ACID SALICYLIC ACID PALMITIC ACID MEDIUM-CHAIN TRIGLYCERIDES ICODEXTRIN POLYDEXTROSE CAPRYLYL GLYCOL CETYL ALCOHOL MYRISTYL ALCOHOL PHENOXYETHANOL TOCOPHEROL OCTYLDODECANOL LAURYL ALCOHOL DIMETHICONE LEVOMENOL LECITHIN, SOYBEAN POLYSORBATE 20 NYMPHAEA CAERULEA FLOWER VOLATILE OIL N-ACETYLGLUCOSAMINE STEARIC ACID SODIUM HYDROXIDE NELUMBO NUCIFERA FLOWER OIL PHYSALIS ANGULATA WHOLE DILINOLEIC ACID/BUTANEDIOL COPOLYMER DOCOSANOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE DIPROPYLENE GLYCOL
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, seek medical help.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed.
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 are more likely to occur when using another topical acne product at the same time. If irritation occurs, use only one acne product at a time. Avoid eye area. In case of eye contact, flush gently and thoroughly with water. Do not apply to broken or irritated skin.
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 are more likely to occur when using another topical acne product at the same time. If irritation occurs, use only one acne product at a time. Avoid eye area. In case of eye contact, flush gently and thoroughly with water. Do not apply to broken or irritated skin. Keep out of reach of children. If swallowed, seek medical help.
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