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| Product NDC Code | 78518-012 | ||||
|---|---|---|---|---|---|
| Drug Name | Acne moisturizer |
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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 | MONAT GLOBAL CORP | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT ACTIVE INGREDIENT: Salicylic Acid 2.00%
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 Directions Clean skin thoroughly before applying this product Apply a dime-sized amount onto fingers. Gently use fingertips to apply to clean and dry face using circular motions 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 Inactive Ingredients: Water, Dimethyl Isosorbide, Glycerin, Sodium Hydroxide, Cetearyl Olivate, Caprylic/Capric Triglyceride, Lactococcus Ferment Lysate, Niacinamide, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sorbitan Isostearate, Polysorbate 60, Polyacrylate Crosspolymer-6, Sorbitan Olivate, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Wax, Acacia Decurrens Flower Wax, Polyglycerin-3, Tocopherol, Coco-Caprylate/Caprate, Triheptanoin, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Castor Oil/IPDI Copolymer, Physalis Angulata Extract, Lactic Acid, Sodium Hyaluronate, 1,2-Hexanediol, Polylysine, Camellia Sinensis Leaf Extract, Potassium Sorbate, Sodium Benzoate, Bisabolol, Pentylene Glycol, Propanediol, Caprylyl Glycol, Ethylhexylglycerin, Sodium Chloride, t-Butyl Alcohol, Chlorphenesin, Phenylpropanol, Levulinic Acid, Sodium Levulinate
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 Uses For the treatment of acne Helps prevent new acne blemishes from forming
Purpose
Information about the drug product’s indications for use.Purpose Purpose Acne Treatment
Spl product data elements
Usually a list of ingredients in a drug product.ACNE Moisturizer SALYCILIC ACID TOCOPHEROL DILINOLEIC ACID/BUTANEDIOL COPOLYMER SODIUM LEVULINATE POTASSIUM SORBATE SODIUM BENZOATE LEVOMENOL SODIUM CHLORIDE TERT-BUTYL ALCOHOL LEVULINIC ACID POLY-L-LYSINE (30000-70000 MW) NIACINAMIDE PROPANEDIOL CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN CHLORPHENESIN PHENYLPROPANOL GREEN TEA LEAF PHYSALIS ANGULATA HYALURONATE SODIUM CETEARYL OLIVATE LACTIC ACID 1,2-HEXANEDIOL HELIANTHUS ANNUUS SEED WAX SALICYLIC ACID SALICYLIC ACID TRIHEPTANOIN DIMETHYL ISOSORBIDE SORBITAN OLIVATE HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) POLYGLYCERIN-3 WATER GLYCERIN PENTYLENE GLYCOL SODIUM HYDROXIDE CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) ACACIA DECURRENS FLOWER WAX COCO-CAPRYLATE/CAPRATE LACTOCOCCUS LACTIS HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) SORBITAN ISOSTEARATE POLYSORBATE 60
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.Primary Package Primary Package Primary Package
Secondary Package Secondary Package Outer package
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 Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center immediately.
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 Questions or comments? Toll-free number 1-800-878-1978
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 consult Stop use and consult with a doctor if irritation becomes severe
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 When using this product skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
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 Warnings For external use only When using this product When using this product skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and consult Stop use and consult with a doctor if irritation becomes severe Keep out of reach of children Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center immediately.
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