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Product NDC Code | 71494-005 | ||||
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Drug Name | Peace out acne hero routine |
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Type | Brand | ||||
Route | TOPICAL | ||||
Dosage Form | KIT | ||||
RxCUI drug identifier | 103568, 1994404 |
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Application Number | M006 | ||||
Labeler Name | Peace Out Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Patch : Salicylic Acid 0.5% Serum : 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 Patch : For products applied to and left on the skin : Cleanse thoroughly before applying this product Cover the entire affected area with one dot Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times a daily if needed or as directed by a doctor If bothersome dryness or peeling occurs, reduce application to once a day or even 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. Serum: 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 Patch : Aloe Barbadensis (Aloe Vera) Leaf Extract, Retinyl Acetate Patch: Hydrocolloid Polymer Technology Serum : Water/Aqua/Eau, Propanediol, Triheptanoin, Coco-Caprylate/Caprate, Niacinamide, Salicylic Acid, Isopentyldiol, Sodium Polyacryloyldimethyl Taurate, Zinc PCA, 3-O-Ethyl Ascorbic Acid, Sodium Hyaluronate, Aloe Barbadensis Leaf, Trifolium Pratense (Clover) Flower Extract, Centella Asiatica Flower/Leaf/Stem Extract, Potassium Azeloyl Diglycinate, Saccharide Isomerate, Cetearyl Olivate, Glycerin, Sorbitan Olivate, Dilinoleic Acid/Butanediol Copolymer, Decyl Glucoside, Caprylyl Glycol, Trisodium Ethylenediamine Disuccinate, Castor Oil/IPDI Copolymer, Phenoxyethanol, Tocopheryl Acetate, Sodium Hydroxide, Ethylhexylglycerin
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 Hero Routine Salicylic Acid Peace Out Repairing Moisturizer WATER TRIHEPTANOIN TRISODIUM ETHYLENEDIAMINE DISUCCINATE ALKYL (C12-15) BENZOATE PHYTOSPHINGOSINE DILINOLEIC ACID/BUTANEDIOL COPOLYMER CITRIC ACID MONOHYDRATE ETHYLHEXYLGLYCERIN PHENOXYETHANOL BAKUCHIOL SALIX ALBA BARK HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) SORBITAN ISOSTEARATE CETEARYL OLIVATE PROPANEDIOL 1,2-HEXANEDIOL CERAMIDE AP UBIDECARENONE PASSIFLORA EDULIS SEED OIL COCO-CAPRYLATE/CAPRATE CHOLESTEROL GLYCERIN NEOPENTYL GLYCOL DIHEPTANOATE SORBITAN OLIVATE NIACINAMIDE MORINGA OLEIFERA SEED OIL ROSA CANINA SEED OIL LAUROYL LYSINE SODIUM LAUROYL LACTYLATE CAPRYLHYDROXAMIC ACID .ALPHA.-TOCOPHEROL ACETATE, D- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE COCONUT ALKANES DIACRONEMA LUTHERI POLYSORBATE 60 CERAMIDE NP CERAMIDE 1 CANNABIS SATIVA SEED OIL Peace Out Acne Salicylic Acid SALICYLIC ACID SALICYLIC ACID VITAMIN A ACETATE ALOE VERA LEAF Peace Out Acne Serum Salicylic Acid ZINC PIDOLATE CETEARYL OLIVATE ETHYLHEXYLGLYCERIN TRIFOLIUM PRATENSE FLOWER GLYCERIN TRISODIUM ETHYLENEDIAMINE DISUCCINATE PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE 3-O-ETHYL ASCORBIC ACID POTASSIUM AZELOYL DIGLYCINATE SORBITAN OLIVATE DECYL GLUCOSIDE CAPRYLYL GLYCOL COCO-CAPRYLATE/CAPRATE NIACINAMIDE HYALURONATE SODIUM CENTELLA ASIATICA SACCHARIDE ISOMERATE DILINOLEIC ACID/BUTANEDIOL COPOLYMER PROPANEDIOL TRIHEPTANOIN ISOPENTYLDIOL SALICYLIC ACID SALICYLIC ACID WATER ALOE VERA LEAF SODIUM HYDROXIDE
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.Packaging hero routine
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
Company Information Distributed by: Peace Out Inc. San Francisco, CA 94103 USA
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Store between 15C - 30C
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? Call toll free 1-800-268-1962 M-F 9AM to 6PM PST
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 one medication should be used. Do not use if you are allergic to the dressing or any of its components.
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 one medication should be used. Do not use if you are allergic to the dressing or any of its components. 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