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Product NDC Code | 71494-102 | ||||
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Drug Name | Peace out acne serum |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
RxCUI drug identifier | 103568 | ||||
Application Number | M006 | ||||
Labeler Name | Peace Out LLC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Salicylic Acid 2%
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 For products applied to and left on the skin: 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 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 above.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (AQUA/EAU), Propanediol, Dimethicone, Sodium Polyacryloyldimethyl Taurate, Niacinamide, Isopentyldiol, Zinc PCA, Potassium Azeloyl Diglycinate, Butylene Glycol, Ethylhexyl Olivate, Polysilicone-11, Potassium Hydroxide, 3-0-Ethyl Ascorbic Acid, Decyl Glucoside, Sodium Acrylates Copolymer, Polyglyceryl-4 Oleate, Tocopheryl Acetate, Glycerin, Caprylyl Glycol, Disodium EDTA, Gentelia Asiatica Extract, Lavandula Hybrida Grosso Herb Oil, Trifolium Pratense (Clover) Flower Extract, Ethylhexylglycerin, Aloe Barbadensis Leaf Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, 1,2-Hexanediol, Sodium Hyaluronate, Phenoxyethanol, Saccharide Isomerate, Maltodextrin, Ethoxydiglycol, Totarol
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
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.Peace Out Acne Serum Salicylic Acid WATER PROPANEDIOL DIMETHICONE NIACINAMIDE ISOPENTYLDIOL SODIUM POLYACRYLOYLDIMETHYL TAURATE ZINC PIDOLATE POTASSIUM AZELOYL DIGLYCINATE ETHYLHEXYL OLIVATE BUTYLENE GLYCOL POTASSIUM HYDROXIDE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) 3-O-ETHYL ASCORBIC ACID .ALPHA.-TOCOPHEROL ACETATE GLYCERIN CAPRYLYL GLYCOL EDETATE DISODIUM ANHYDROUS CENTELLA ASIATICA WHOLE LAVANDIN OIL TRIFOLIUM PRATENSE FLOWER ETHYLHEXYLGLYCERIN ALOE VERA LEAF BERGAMOT OIL 1,2-HEXANEDIOL HYALURONATE SODIUM PHENOXYETHANOL SACCHARIDE ISOMERATE MALTODEXTRIN DIETHYLENE GLYCOL MONOETHYL ETHER TOTAROL SALICYLIC ACID SALICYLIC ACID POLYGLYCERYL-4 OLEATE DECYL GLUCOSIDE
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.Principal Display Panel 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-268-1962
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 skin irriation occurs.
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 if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication 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 For external use only. 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 medication at a time avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water Stop use and ask a doctor if skin irriation 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